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• controllerapplications
• actionindex
• named(array)
  • page1
  • sortapproval_date
  • directiondesc
  • statusapproved
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  • Application(array)
    • page1
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    • count26
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      • Application.approval_datedesc
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    • options(array)
      • order(array)
        • Application.approval_datedesc
      • sortapproval_date
      • directiondesc
    • paramTypenamed

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• Application(array)
  • statusapproved

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View Variables

• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
  • 10Paused or preparation for extension of study
  • 11Revoked
  • 12Ongoing Closeout Phase
• action_date_fieldapproval_date
• statusapproved
• applications(array)
  • 0(array)
    • Application(array)
      • id256
      • user_id869
      • application_id(null)
      • is_child0
      • trial_status_id(null)
      • trial_status_date(null)
      • total_sites1
      • abstract_of_study<p>\n Malaria continues to be a significant public health concern, particularly in regions where the disease is endemic. New treatment options are needed to improve patient outcomes and address emerging drug resistance.</p>\n
      • study_title<p>\n antimalaria2</p>\n
      • laymans_summary<p>\n Malaria remains a major health challenge in many countries. This study aims to evaluate a new treatment for malaria and compare it with the current standard treatment. Adults diagnosed with uncomplicated malaria will be invited to participate and will be randomly assigned to receive either the new treatment or the standard treatment. </p>\n
      • short_titletest sample
      • protocol_noECCT/26/06/01
      • reference_no(null)
      • version_nov53
      • date_of_protocol09-06-2026
      • study_drugantimaliria2
      • disease_conditionmalaria
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmkorir600+3@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi0
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan0
      • applicant_contractual_agreement0
      • declaration_applicant0712345678
      • declaration_date109-06-2026
      • declaration_principal_investigatorprincipal investigator
      • declaration_date209-06-2026
      • protocol_not_ai_generated0
      • placebo_presentNo
      • study_objectives<p>\n To evaluate the safety and effectiveness of a new antimalarial drug in treating uncomplicated malaria.</p>\n
      • principal_inclusion_criteria<p>\n <strong>Be <strong data-end=\"385\" data-start=\"363\">18 years and above</strong></strong></p>\n<p>\n <strong>Have <strong data-end=\"462\" data-start=\"393\">confirmed uncomplicated malaria infection (Plasmodium falciparum)</strong></strong></p>\n<p>\n <strong>Be able to <strong data-end=\"504\" data-start=\"476\">provide informed consent</strong></strong></p>\n<p>\n <strong>Be willing to <strong data-end=\"574\" data-start=\"521\">comply with study procedures and follow-up visits</strong></strong></p>\n
      • principal_exclusion_criteria<p>\n <strong>Have <strong data-end=\"397\" data-start=\"364\">severe or complicated malaria</strong></strong></p>\n<p>\n <strong>Are <strong data-end=\"433\" data-start=\"404\">pregnant or breastfeeding</strong> (if the study drug is not proven safe in pregnancy)</strong></p>\n<p>\n <strong>Have <strong data-end=\"530\" data-start=\"493\">known allergy or hypersensitivity</strong> to the study drug or related medications</strong></p>\n<p>\n <strong>Have <strong data-end=\"608\" data-start=\"579\">serious chronic illnesses</strong> (e.g., severe liver, kidney, or heart disease)</strong></p>\n<p>\n <strong>Have received <strong data-end=\"722\" data-start=\"672\">antimalarial treatment within the last 14 days</strong></strong></p>\n<p>\n <strong>Are <strong data-end=\"791\" data-start=\"729\">unable to comply with study procedures or follow-up visits</strong></strong></p>\n<p>\n <strong>Are participating in <strong data-end=\"858\" data-start=\"815\">another clinical trial at the same time</strong></strong></p>\n
      • primary_end_points<p>\n Treatment success rate at Day 28</p>\n<p>\n  </p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n ffghghj</p>\n
      • other_details_explanation<p>\n kjjnm</p>\n
      • other_details_regulatory_notapproved<p>\n vbbvbv</p>\n
      • other_details_regulatory_approved<p>\n nbbn</p>\n
      • other_details_regulatory_rejected<p>\n bnbbvo</p>\n
      • other_details_regulatory_halted<p>\n bvvbv</p>\n
      • estimated_duration12 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areammust
      • single_site_physical_address123, kk
      • single_site_contact_personHOR
      • single_site_telephone0712345678
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site5
      • total_participants_worldwide1000
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namelucy
      • investigator1_middle_namelucy
      • investigator1_family_namelucy
      • investigator1_qualificationqual
      • investigator1_professional_addressspicemercy8+1@gmail.com
      • investigator1_telephone0712345678
      • investigator1_emailspicemercy8+1@gmail.com
      • organisations_transferred_No
      • number_participants100
      • notification<p>\n bbvb</p>\n
      • approval_date10-06-2026
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-06-2026
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasongood
      • approved_date(null)
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice460442
      • modified2026-06-10 06:33:19
      • created2026-06-09 21:11:17
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id181
        • application_id256
        • given_namemercy
        • middle_name
        • family_namemercy
        • qualificationqual
        • professional_addressmkorir600+3@gmail.com
        • telephone0734655152
        • emailmkorir600+3@gmail.com
        • investigator_roleprincipal
        • created2026-06-09 21:16:53
        • modified2026-06-09 21:40:35
    • SiteDetail(array)
      • 0(array)
        • id1766
        • application_id256
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2026-06-09 21:16:53
        • modified2026-06-09 21:40:35
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id78
        • application_id256
        • sponsormmust
        • sponsor_typeResearch Institution
        • contact_personHead of reseach mmust
        • address123,kk
        • telephone_number0712345678
        • fax_number
        • cell_number0712345678
        • email_addressreasearch@gmail.com
        • created2026-06-09 21:16:53
        • modified2026-06-09 21:40:35
    • PublicAction(array)
      • labelApproved
      • date10-06-2026
  • 1(array)
    • Application(array)
      • id249
      • user_id29
      • application_id(null)
      • is_child0
      • trial_status_id7
      • trial_status_date(null)
      • total_sites4
      • abstract_of_study<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • study_title<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • laymans_summary<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • short_titleReprehenderit dolor adipisci
      • protocol_noECCT/26/02/03
      • reference_no(null)
      • version_noVeniam consequuntur minus rerum dolor labore voluptate
      • date_of_protocol23-02-2026
      • study_drugEt totam sunt duis expedita exercitationem officia earum ipsa esse sunt esse esse pariatur Ea ullam et quae commodi numquam
      • disease_conditionSit et aut iste soluta eum quia impedit minus nisi
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_nameAhmed Franklin
      • product_type_medical_device_nameSamson Franco
      • comparatorYes
      • comparator_nameJenette Trevino
      • comparator_registeredImpedit maxime qui animi qui
      • comparator_countriesSuscipit sed sequi m
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi0
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan0
      • applicant_contractual_agreement0
      • declaration_applicantMaiores et in dolores autem voluptas aliquam maxime tempore delectus voluptas tenetur voluptas
      • declaration_date123-02-2026
      • declaration_principal_investigatorNihil enim itaque sapiente consequuntur et dolor ea deserunt deleniti dolor praesentium natus qui aliquam eveniet magnam maxime quisquam dolore
      • declaration_date223-02-2026
      • protocol_not_ai_generated0
      • placebo_presentYes
      • study_objectives<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • principal_inclusion_criteria<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • principal_exclusion_criteria<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • primary_end_points<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence1
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others1
      • scope_others_specifyAliqua Cumque aut s
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study1
      • trial_other1
      • trial_other_specifyNatus velit et ut et
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • other_details_explanation<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • other_details_regulatory_notapproved<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • other_details_regulatory_approved<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • other_details_regulatory_rejected<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • other_details_regulatory_halted<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • estimated_duration8
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overYes
      • design_controlled_otherYes
      • design_controlled_specifyAd soluta eiusmod cupiditate veritatis et reiciendis ut voluptas quibusdam repellendus Et Nam
      • design_controlled_comparatorIure dolor enim cum tempo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyEius proident sed minim adipisci ab praesentium dolores eaque
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states588
      • number_of_sites51
      • multi_country_listId vel itaque saepe
      • data_monitoring_committeeNo
      • total_enrolment_per_siteEu numquam sed quis
      • total_participants_worldwidePlaceat dolore fugiat illum ut deserunt quos dolorum quam iste sed deleniti quia commodi quas eaque odio proident quam facilis
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyIncidunt quia sed c
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameQuon Trevino
      • investigator1_middle_nameHoyt Delgado
      • investigator1_family_nameCandace Mathews
      • investigator1_qualificationSapiente consectetur iste pariatur Sit id perspiciatis proident rerum explicabo Culpa maxime placeat ipsum in
      • investigator1_professional_addressSoluta at nisi tenetur reprehenderit nisi ex enim culpa voluptas exercitation quaerat beatae cumque temporibus rerum
      • investigator1_telephone+1 (145) 424-8512
      • investigator1_emailsota@mailinator.com
      • organisations_transferred_Yes
      • number_participantsHic ducimus quas el
      • notification<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • approval_date25-05-2026
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-02-2026
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • approved_date(null)
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice436616
      • modified2026-06-24 14:25:09
      • created2026-02-23 07:03:19
      • ai_content1
    • InvestigatorContact(array)
      • 0(array)
        • id172
        • application_id249
        • given_nameXaviera Wood
        • middle_nameGareth Cruz
        • family_nameHu Hatfield
        • qualificationOdit ut architecto qui et praesentium saepe ut officia quia quibusdam totam veniam anim
        • professional_addressSunt id sit et veniam reprehenderit
        • telephone+1 (327) 595-5182
        • emailfyhi@mailinator.com
        • investigator_roleco_pi
        • created2026-02-23 07:08:37
        • modified2026-02-23 07:08:37
      • 1(array)
        • id173
        • application_id249
        • given_nameEdan Robles
        • middle_nameCarly Rodriguez
        • family_nameBruce Love
        • qualificationQui voluptate consectetur natus consectetur quia quia odit sapiente dolores vitae porro voluptate duis id molestiae itaque in culpa modi
        • professional_addressAd non amet quo nihil aspernatur quis ut assumenda facilis cumque obcaecati dolor
        • telephone+1 (709) 598-5372
        • emailpibuvymy@mailinator.com
        • investigator_roleco_i
        • created2026-02-23 07:08:37
        • modified2026-02-23 07:08:37
      • 2(array)
        • id174
        • application_id249
        • given_nameChava Carlson
        • middle_nameValentine Merritt
        • family_nameEugenia Pearson
        • qualificationConsectetur eaque ad duis dicta architecto laudantium repellendus Nostrum esse est repudiandae laboriosam
        • professional_addressDeleniti nulla quidem error ex
        • telephone+1 (983) 663-4323
        • emailhiba@mailinator.com
        • investigator_roleprincipal
        • created2026-02-23 07:08:37
        • modified2026-02-23 07:08:37
    • SiteDetail(array)
      • 0(array)
        • id1765
        • application_id249
        • county_id35
        • site_nameDominique Daugherty
        • physical_addressEiusmod autem sed sapiente voluptatem nihil ullam magnam odio et
        • contact_detailsP.O. Box 83526
        • contact_personDo quidem neque voluptas est dolorem vero eligendi veniam nihil sunt quibusdam quo tempor pariatur Obcaecati magnam et
        • site_capacity(null)
        • misc(null)
        • created2026-02-23 07:08:37
        • modified2026-02-23 07:08:37
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
    • Sponsor(array)
      • 0(array)
        • id75
        • application_id249
        • sponsorSint esse rerum illo tempor ex velit animi molestiae magnam
        • sponsor_typeLocal Kenyan Investigator
        • contact_personQuae ut deleniti quidem quidem totam quod quia
        • addressTempor qui obcaecati nostrum tenetur dolor perspiciatis sint magni
        • telephone_number+1 (957) 328-2251
        • fax_number+1 (686) 994-8364
        • cell_number+1 (761) 946-8678
        • email_addresswohafahibi@mailinator.com
        • created2026-02-23 07:08:37
        • modified2026-02-23 07:08:37
      • 1(array)
        • id76
        • application_id249
        • sponsorEa nesciunt pariatur Nemo excepturi aut est cillum numquam
        • sponsor_typeOthers
        • contact_personDoloribus enim et at ipsum distinctio Perferendis reprehenderit magni eu explicabo Quia reiciendis perferendis omnis architecto nulla sit tempore reiciendis
        • addressCommodo non quis est adipisci quaerat
        • telephone_number+1 (117) 101-1532
        • fax_number+1 (384) 353-8905
        • cell_number+1 (161) 424-2784
        • email_addresshejybemo@mailinator.com
        • created2026-02-23 07:08:37
        • modified2026-02-23 07:08:37
    • PublicAction(array)
      • labelApproved
      • date25-05-2026
  • 2(array)
    • Application(array)
      • id248
      • user_id29
      • application_id(null)
      • is_child0
      • trial_status_id(null)
      • trial_status_date(null)
      • total_sites3
      • abstract_of_study<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • study_title<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • laymans_summary<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • short_titleQui exercitation ut officia ob
      • protocol_noECCT/26/02/02
      • reference_no(null)
      • version_noMolestiae expedita dolores aliquam blanditiis excepteur
      • date_of_protocol23-02-2026
      • study_drugOfficia dolores suscipit dignissimos porro quos aut magna aut asperiores quis
      • disease_conditionQuis soluta consectetur aut ipsam aute commodi quia
      • product_type_biologicals0
      • product_type_proteins1
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_nameMorgan Goff
      • product_type_medical_device_nameAlexis Workman
      • comparatorYes
      • comparator_nameMartina Glover
      • comparator_registeredCillum deserunt cumque tenetur
      • comparator_countriesDolor ipsam illum n
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi0
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan0
      • applicant_contractual_agreement0
      • declaration_applicantCommodi quisquam proident excepturi cum et atque qui voluptas sed commodi ad
      • declaration_date123-02-2026
      • declaration_principal_investigatorEaque ex aut omnis velit enim odit ut aut aut quis totam fugit nisi est enim maiores molestiae
      • declaration_date223-02-2026
      • protocol_not_ai_generated0
      • placebo_presentYes
      • study_objectives<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • principal_inclusion_criteria<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • principal_exclusion_criteria<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • primary_end_points<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence1
      • scope_dose_response1
      • scope_pharmacogenetic1
      • scope_pharmacogenomic1
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other1
      • trial_other_specifyRerum itaque eu illo
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • other_details_explanation<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • other_details_regulatory_notapproved<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • other_details_regulatory_approved<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • other_details_regulatory_rejected<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • other_details_regulatory_halted<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • estimated_duration4
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherYes
      • design_controlled_specifyQuasi sint deserunt totam libero voluptate tenetur voluptas ut dolor blanditiis sed sunt magni eu provident ut voluptate
      • design_controlled_comparatorExpedita anim aut deserun
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites4
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_sitePorro non adipisicin
      • total_participants_worldwideVoluptatum alias rerum voluptatem laudantium labore proident consequatur mollitia
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDominic Douglas
      • investigator1_middle_nameRonan Jimenez
      • investigator1_family_nameAline Spears
      • investigator1_qualificationEos quasi esse amet ut corporis
      • investigator1_professional_addressMagni nihil et quas in similique magna velit ut et pariatur Eos sunt
      • investigator1_telephone+1 (392) 378-2765
      • investigator1_emailtofesegete@mailinator.com
      • organisations_transferred_Yes
      • number_participantsSunt quisquam quia i
      • notification<p>\n Clinical trials are carefully designed research studies conducted in human participants to evaluate the safety, efficacy, and overall effectiveness of new medical interventions such as drugs, vaccines, diagnostic tools, or treatment procedures. They follow a structured process—typically organized into phases—to ensure that potential therapies are rigorously tested before being approved for widespread use. Guided by ethical principles, regulatory oversight, and informed consent, clinical trials aim to protect participants while generating reliable scientific evidence that advances medical knowledge, improves patient care, and contributes to better health outcomes globally.</p>\n
      • approval_date23-03-2026
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-02-2026
      • unsubmitted1
      • initial_date_submitted23-02-2026
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • approved_date(null)
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice436615
      • modified2026-03-23 12:03:26
      • created2026-02-23 06:56:12
      • ai_content1
    • InvestigatorContact(array)
      • 0(array)
        • id168
        • application_id248
        • given_nameMolly White
        • middle_nameKalia Stanley
        • family_nameSamuel Rollins
        • qualificationNon nulla dolores deleniti eiusmod aute ut minus et anim velit velit
        • professional_addressNisi magna rerum consequatur deleniti voluptate dignissimos numquam sit sit ex est maxime
        • telephone+1 (875) 993-2663
        • emailhazif@mailinator.com
        • investigator_roleco_pi
        • created2026-02-23 07:01:57
        • modified2026-02-25 12:07:29
      • 1(array)
        • id169
        • application_id248
        • given_nameTyrone Henson
        • middle_nameEleanor Johns
        • family_nameNoble Harrison
        • qualificationLaborum Excepturi numquam sequi iusto aut corporis dolor non
        • professional_addressMagnam quas mollit dolores accusamus qui laboriosam laboris sit iure officia harum
        • telephone+1 (713) 669-8451
        • emailcymohu@mailinator.com
        • investigator_roleco_i
        • created2026-02-23 07:01:57
        • modified2026-02-25 12:07:29
      • 2(array)
        • id170
        • application_id248
        • given_nameJayme Morales
        • middle_nameKamal West
        • family_nameXaviera Park
        • qualificationEt veritatis quia maiores pariatur Ut fugiat voluptatem magna quod iusto sapiente sunt laborum duis explicabo Fuga Consequuntur amet dolor
        • professional_addressSunt nostrud provident ut aut est ea sed reiciendis voluptate anim qui culpa et dolore eaque
        • telephone+1 (652) 498-7279
        • emailsemefal@mailinator.com
        • investigator_roleprincipal
        • created2026-02-23 07:01:57
        • modified2026-02-25 12:07:29
    • SiteDetail(array)
      • 0(array)
        • id225
        • application_id248
        • county_id19
        • site_nameStone Landry
        • physical_addressItaque autem debitis nemo reprehenderit sit consequatur
        • contact_detailsPO Box 55
        • contact_personCorrupti molestias ipsam voluptatem Id eiusmod qui tempora quis optio dignissimos laboris recusandae Ducimus consequat Ratione accusamus
        • site_capacity(null)
        • misc(null)
        • created2013-12-19 10:53:20
        • modified2026-02-25 12:07:29
        • County(array)
          • id19
          • county_nameNyeri
          • created2012-06-15 10:24:16
          • modified2012-06-15 10:24:16
    • Sponsor(array)
      • 0(array)
        • id74
        • application_id248
        • sponsorIn sit blanditiis esse dolores eius sunt
        • sponsor_typeOthers
        • contact_personSint asperiores doloribus velit voluptatem dolor sed dolor ullamco ea consectetur quia sint ipsam nisi veniam
        • addressAlias eum veniam incididunt vitae cumque laborum esse sapiente possimus deleniti dolorum sed
        • telephone_number+1 (173) 528-1736
        • fax_number+1 (825) 352-3303
        • cell_number+1 (993) 549-7521
        • email_addressmoxuji@mailinator.com
        • created2026-02-23 07:01:57
        • modified2026-02-25 12:07:29
    • PublicAction(array)
      • labelApproved
      • date23-03-2026
  • 3(array)
    • Application(array)
      • id231
      • user_id29
      • application_id(null)
      • is_child0
      • trial_status_id6
      • trial_status_date(null)
      • total_sites2
      • abstract_of_study<p>\n Sample</p>\n
      • study_title<p>\n Sample sample</p>\n
      • laymans_summary<p>\n test</p>\n
      • short_titleTest
      • protocol_noECCT/25/07/01
      • reference_no
      • version_no3
      • date_of_protocol11-07-2025
      • study_drugSample
      • disease_conditionSample
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_namesample
      • product_type_medical_device_name
      • comparatorYes
      • comparator_namesample
      • comparator_registeredsample
      • comparator_countriessample,sample
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi0
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan0
      • applicant_contractual_agreement0
      • declaration_applicantsample sample
      • declaration_date111-07-2025
      • declaration_principal_investigatorSample Sample
      • declaration_date211-07-2025
      • protocol_not_ai_generated0
      • placebo_presentNo
      • study_objectives<p>\n sample sample</p>\n
      • principal_inclusion_criteria<p>\n saample</p>\n
      • principal_exclusion_criteria<p>\n sample</p>\n
      • primary_end_points<p>\n sample</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n sample sample</p>\n
      • other_details_explanation<p>\n sample sample</p>\n
      • other_details_regulatory_notapproved<p>\n sample</p>\n
      • other_details_regulatory_approved<p>\n sample</p>\n
      • other_details_regulatory_rejected<p>\n sample</p>\n
      • other_details_regulatory_halted<p>\n sample</p>\n
      • estimated_duration3
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areasample sample
      • single_site_physical_addresssample sample
      • single_site_contact_personsample
      • single_site_telephone0733098232
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site40
      • total_participants_worldwide40
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namesample sample
      • investigator1_middle_namesample
      • investigator1_family_namesample sample
      • investigator1_qualificationsample
      • investigator1_professional_addresssample
      • investigator1_telephone0700543987
      • investigator1_emailsample@gmail.com
      • organisations_transferred_No
      • number_participants30
      • notification<p>\n Sample docs</p>\n
      • approval_date30-09-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-07-2025
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasontest
      • approved_date(null)
      • final_report<p>\n test</p>\n
      • implication_results<p>\n test</p>\n
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      • final_date2025-09-30
      • ecitizen_invoice363835
      • modified2026-02-17 10:47:21
      • created2025-03-27 12:53:06
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        • id146
        • application_id231
        • given_nameKiprotich
        • middle_nameKeter
        • family_nameJapheth
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        • telephone0724743789
        • emailitsjkiprotich@gmail.com
        • investigator_roleprincipal
        • created2025-03-27 12:53:06
        • modified2025-07-11 17:33:23
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        • modified2025-07-11 17:33:23
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        • cell_number07005439292
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        • created2025-03-27 12:54:56
        • modified2025-07-11 17:33:23
    • PublicAction(array)
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    • Application(array)
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      • abstract_of_study<p>\n This prospective multi-center study aims to evaluate the impact of telemedicine on postoperative recovery in patients who have undergone cardiac surgery. A total of 500 patients from five major hospitals will be enrolled and monitored for six months post-surgery. Participants will be divided into two groups: one receiving traditional in-person follow-up care, and the other receiving regular telemedicine consultations. Primary outcomes include readmission rates, complication rates, and patient satisfaction. Secondary outcomes focus on recovery time and healthcare costs. Initial findings indicate that telemedicine may enhance patient outcomes by providing timely medical advice and reducing the need for hospital visits. This study will contribute to understanding the role of telemedicine in improving postoperative care for cardiac surgery patients.</p>\n
      • study_title<p>\n Evaluating the Impact of Telemedicine on Postoperative Recovery in Cardiac Surgery Patients: A Multi-Center Prospective Study</p>\n
      • laymans_summary<p>\n This research looks at how using telemedicine (video calls with doctors) affects recovery after heart surgery. By studying patients from multiple hospitals, the researchers aim to see if virtual follow-ups can help patients heal better and faster compared to traditional in-person visits.</p>\n
      • short_titlestudy 4
      • protocol_noECCT/24/06/04 - A
      • reference_no
      • version_no1.0
      • date_of_protocol20-06-2024
      • study_drugCanagliflozin
      • disease_conditionType 2 Diabetes Mellitus
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameCanagliflozin
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjayoma@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
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      • applicant_complete_form(null)
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      • applicant_pan_african1
      • applicant_hard_copies(null)
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      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantJames McCurrly
      • declaration_date120-06-2024
      • declaration_principal_investigatorPI Inv
      • declaration_date220-06-2024
      • protocol_not_ai_generated0
      • placebo_presentNo
      • study_objectives<ul>\n <li>\n <p>\n <strong>Primary Objective:</strong></p>\n <ul>\n <li>\n To investigate the effect of canagliflozin on glycemic control, measured by changes in HbA1c levels, in patients with type 2 diabetes mellitus over a 24-week treatment period.</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Secondary Objective:</strong></p>\n <ul>\n <li>\n To assess changes in body weight, blood pressure, and lipid profile in patients treated with canagliflozin.</li>\n <li>\n To evaluate the safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus.</li>\n <li>\n To explore patient-reported outcomes related to quality of life and treatment satisfaction with canagliflozin therapy.</li>\n </ul>\n </li>\n</ul>\n
      • principal_inclusion_criteria<ul>\n <li>\n <p>\n <strong>Type 2 Diabetes Mellitus diagnosis:</strong></p>\n <ul>\n <li>\n Patients must have a documented diagnosis of type 2 diabetes mellitus.</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Inadequate glycemic control:</strong></p>\n <ul>\n <li>\n Patients must have inadequate glycemic control defined as HbA1c levels between 7.5% and 10.5% despite treatment with stable doses of metformin alone or in combination with other oral antidiabetic agents</li>\n </ul>\n </li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n <p>\n <strong>Renal impairment:</strong></p>\n <ul>\n <li>\n Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) or end-stage renal disease requiring dialysis are excluded.</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Cardiovascular events:</strong></p>\n <ul>\n <li>\n Patients with a history of recent cardiovascular events such as myocardial infarction, stroke, or unstable angina within the past 3 months are excluded.</li>\n </ul>\n </li>\n</ul>\n
      • primary_end_points<ul>\n <li>\n <p>\n <strong>Primary Endpoint 1: Change in HbA1c Levels</strong></p>\n <ul>\n <li>\n The primary endpoint is the change in HbA1c levels from baseline to week 24 in patients treated with canagliflozin compared to placebo or standard treatment. HbA1c reflects average blood glucose levels over the past 2-3 months and is a key measure of glycemic control in diabetes.</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Primary Endpoint 2: Incidence of Adverse Cardiovascular Events</strong></p>\n <ul>\n <li>\n Another primary endpoint is the incidence of adverse cardiovascular events (e.g., myocardial infarction, stroke, cardiovascular death) during the treatment period with canagliflozin compared to placebo or standard treatment. This endpoint assesses the cardiovascular safety profile of canagliflozin in patients with type 2 diabetes mellitus.</li>\n </ul>\n </li>\n</ul>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Capacity of Site:</strong></p>\n<ul>\n <li>\n Leading academic medical center with extensive research capabilities.</li>\n</ul>\n<p>\n <strong>Number of Staff and Facilities:</strong></p>\n<ul>\n <li>\n <p>\n <strong>Study Coordinators:</strong></p>\n <ul>\n <li>\n Laura Marie Smith, MD, FACP (Coordinating Investigator)</li>\n <li>\n John William Davies, PharmD (Pharmacist)</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Other Staff:</strong></p>\n <ul>\n <li>\n Specialists in endocrinology, diabetes, and metabolism.</li>\n <li>\n Research nurses, clinical trial coordinators.</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Site Facilities:</strong></p>\n <ul>\n <li>\n Advanced laboratories for research.</li>\n <li>\n Comprehensive patient care facilities.</li>\n <li>\n High-tech diagnostic and treatment equipment.</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Emergency Facilities:</strong></p>\n <ul>\n <li>\n Level I trauma center.</li>\n <li>\n Rapid response teams and critical care capabilities.</li>\n </ul>\n </li>\n</ul>\n
      • other_details_explanation<ol>\n <li>\n <ul>\n <li>\n Kenya has a significant prevalence of type 2 diabetes mellitus, providing a suitable patient population for studying the efficacy and safety of canagliflozin. This ensures adequate enrollment of eligible participants.</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Ethnic Diversity and Genetic Variability:</strong></p>\n <ul>\n <li>\n The ethnic diversity in Kenya offers an opportunity to study the response to canagliflozin across different genetic backgrounds. Understanding genetic variability can provide insights into personalized treatment approaches.</li>\n </ul>\n </li>\n</ol>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n <strong>Name of Regulatory Authorities:</strong></p>\n<ul>\n <li>\n MHRA (Medicines and Healthcare products Regulatory Agency), UK</li>\n <li>\n TGA (Therapeutic Goods Administration), Australia</li>\n</ul>\n<p>\n <strong>Date(s) of Application:</strong></p>\n<ul>\n <li>\n MHRA: March 10, 2024</li>\n <li>\n TGA: April 5, 2024</li>\n</ul>\n
      • other_details_regulatory_approved<ul>\n <li>\n <p>\n <strong>MHRA (Medicines and Healthcare products Regulatory Agency), UK</strong></p>\n <ul>\n <li>\n <strong>Date of Approval:</strong> April 20, 2024</li>\n <li>\n <strong>Number of Sites per Country:</strong>\n <ul>\n <li>\n UK: 12 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n <p>\n <strong>TGA (Therapeutic Goods Administration), Australia</strong></p>\n <ul>\n <li>\n <strong>Date of Approval:</strong> May 5, 2024</li>\n <li>\n <strong>Number of Sites per Country:</strong>\n <ul>\n <li>\n Australia: 8 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n</ul>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration24 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areatest site2
      • single_site_physical_addressTEST
      • single_site_contact_personJoel Justin
      • single_site_telephone+254709283746
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site200000
      • total_participants_worldwide20000000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameMichael
      • investigator1_middle_name
      • investigator1_family_nameThompson
      • investigator1_qualificationMD, MPH
      • investigator1_professional_addressDepartment of Medicine University of Texas MD Anderson Cancer Center 1515 Holcombe Blvd Houston, TX 77030 United States
      • investigator1_telephone +1 713-792-2121
      • investigator1_emailmathompson@mdanderson.org
      • organisations_transferred_No
      • number_participants2000000
      • notification<p>\n N/A</p>\n
      • approval_date11-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-02-2025
      • unsubmitted1
      • initial_date_submitted20-06-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • approved_date(null)
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      • final_date(null)
      • ecitizen_invoice305957
      • modified2025-04-11 08:01:54
      • created2025-02-18 09:40:19
      • ai_content(null)
    • InvestigatorContact(array)
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        • id110
        • application_id191
        • given_nameJavan
        • middle_name
        • family_nameAyoma
        • qualificationMasters
        • professional_addressMsc Drive
        • telephone+254702674563
        • emailjayoma@intellisoftkenya.com
        • investigator_roleprincipal
        • created2024-06-20 10:44:12
        • modified2025-02-18 09:59:26
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        • created2024-06-20 10:55:03
        • modified2025-02-18 09:59:26
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    • Sponsor(array)
      • 0(array)
        • id46
        • application_id191
        • sponsorBioPharma Innovations Ltd.
        • sponsor_typeIndustry
        • contact_person
        • addressBioPharma Innovations Ltd. 123 Main Street San Francisco, CA 94105 United States
        • telephone_number+1 415-555-6789
        • fax_number
        • cell_number+1 415-555-6778
        • email_addressinfo@biopharmainnovations.com
        • created2024-06-20 10:55:03
        • modified2025-02-18 09:59:26
    • PublicAction(array)
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      • date11-04-2025
  • 5(array)
    • Application(array)
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      • abstract_of_study<p>\n <em>Background:</em> The Novacov-24 virus, a newly identified respiratory pathogen, has raised global health concerns due to its rapid spread and potential for severe illness. Effective antiviral treatments are urgently needed to reduce symptom severity, prevent complications, and lower hospitalization rates.</p>\n<p>\n <em>Objective:</em> This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of <em>Virunex-3</em>, a novel antiviral agent, in reducing the severity and duration of symptoms in patients infected with the Novacov-24 virus.</p>\n<p>\n <em>Methods:</em> A total of 500 adult participants with confirmed Novacov-24 infection will be enrolled. Participants will be randomly assigned to receive either <em>Virunex-3</em> (100 mg orally, once daily for 7 days) or a placebo. Primary outcomes will include the reduction of viral load and symptom resolution within 7 days. Secondary outcomes will assess hospitalization rates, need for mechanical ventilation, and mortality. Adverse events and treatment safety will also be monitored.</p>\n<p>\n <em>Expected Outcomes:</em> The study aims to determine whether <em>Virunex-3</em> can effectively reduce symptoms and improve patient recovery while ensuring safety. If successful, this trial could contribute to the development of a new standard of care for Novacov-24 infection.</p>\n<p>\n <em>Conclusion:</em> By assessing both the effectiveness and safety of <em>Virunex-3</em>, this trial will provide valuable insights into managing Novacov-24 and preventing severe health outcomes.</p>\n
      • study_title<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • laymans_summary<p>\n This study is designed to test a new antiviral medication called <em>Virunex-3</em> to see if it can help people recover faster from an illness caused by a newly identified virus called <em>Novacov-24</em>. Participants in the study will either receive <em>Virunex-3</em> or a placebo (a pill with no active ingredients) without knowing which one they are getting. The goal is to find out if <em>Virunex-3</em> can reduce symptoms more quickly, lower the need for hospital care, and prevent serious complications. The results will help doctors understand if this new treatment is safe and effective for fighting the virus.</p>\n
      • short_titleVirunex-3 Trial for Novacov-24
      • protocol_noECCT/25/01/09- KPCTYn
      • reference_no1234redwsqa
      • version_nov1
      • date_of_protocol01-01-2025
      • study_drugVirunex-3
      • disease_conditionNovacov-24 Virus Infection
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
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      • applicant_investigators_cv1
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      • applicant_indemnity_cover1
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      • applicant_hard_copies(null)
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      • applicant_contractual_agreement1
      • declaration_applicantOfficia quasi sunt ab ducimus eaque consectetur aut hic modi omnis
      • declaration_date110-01-2025
      • declaration_principal_investigatorCupidatat consectetur consequuntur fugiat labore necessitatibus dolore est saepe dolorem cumque aliquid aliqua In id quibusdam accusamus
      • declaration_date209-01-2025
      • protocol_not_ai_generated0
      • placebo_presentYes
      • study_objectives<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_inclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_exclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • primary_end_points<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others1
      • scope_others_specifyIn odit voluptate fu
      • trial_human_pharmacology0
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyVoluptas veniam ut
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_explanation<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_notapproved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_approved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_durationTempore id architecto quaerat ad vel
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherYes
      • design_controlled_specifyQuo magna rerum dolor et atque adipisci esse nostrum
      • design_controlled_comparatorAut qui perspiciatis rei
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifySed iste tempore quia tempore tempor repudiandae molestias explicabo Omnis cum et asperiores vel est
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states668
      • number_of_sites9
      • multi_country_listAdipisicing et numqu
      • data_monitoring_committeeYes
      • total_enrolment_per_siteVitae voluptatem se
      • total_participants_worldwideAutem ut aut commodo quas eaque velit dolore proident adipisicing eaque lorem sunt doloribus dolor quo pariatur
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyId tempora omnis vol
      • subjects_othersYes
      • subjects_others_specifyUllam laborum Eos
      • investigator1_given_nameIlliana Ferguson
      • investigator1_middle_nameAllen Fox
      • investigator1_family_nameYolanda Rivera
      • investigator1_qualificationAut labore non sed sed aut iusto et asperiores eu ut ut do qui ullam aut obcaecati earum modi in
      • investigator1_professional_addressEst doloremque dolores adipisicing quidem laboris voluptates vitae ex
      • investigator1_telephone+1 (621) 831-1153
      • investigator1_emailqeryrilu@mailinator.com
      • organisations_transferred_Yes
      • number_participantsMinim dolor commodo
      • notification
      • approval_date13-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-01-2025
      • unsubmitted1
      • initial_date_submitted07-01-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThis is approved
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      • ecitizen_invoice324073
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      • created2024-10-17 10:21:33
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        • application_id118
        • given_nameHiroko Lewis
        • middle_nameTatyana Medina
        • family_nameCastor Gallagher
        • qualificationQuis molestiae voluptate aut aliquam velit est consequat Asperiores possimus et neque molestias aliqua Omnis voluptas non dolor nulla laudantium
        • professional_addressNisi qui dolor optio tempore quisquam laborum Suscipit
        • telephone+1 (322) 766-3057
        • emailtipyhuqo@mailinator.com
        • investigator_roleprincipal
        • created2025-01-13 12:13:08
        • modified2025-02-06 10:49:58
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        • contact_detailsP.O. Box 10
        • contact_personExcepturi culpa dolore vero ut blanditiis aliquam error exercitation dolore reiciendis harum molestiae molestiae magnam fugit
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    • Sponsor(array)
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        • sponsor_typeLocal Kenyan Investigator
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        • fax_number+1 (314) 248-5575
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        • email_addresstuhokelyh@mailinator.com
        • created2025-01-13 12:13:08
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    • PublicAction(array)
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    • Application(array)
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      • abstract_of_study<p>\n <em>Background:</em> The Novacov-24 virus, a newly identified respiratory pathogen, has raised global health concerns due to its rapid spread and potential for severe illness. Effective antiviral treatments are urgently needed to reduce symptom severity, prevent complications, and lower hospitalization rates.</p>\n<p>\n <em>Objective:</em> This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of <em>Virunex-3</em>, a novel antiviral agent, in reducing the severity and duration of symptoms in patients infected with the Novacov-24 virus.</p>\n<p>\n <em>Methods:</em> A total of 500 adult participants with confirmed Novacov-24 infection will be enrolled. Participants will be randomly assigned to receive either <em>Virunex-3</em> (100 mg orally, once daily for 7 days) or a placebo. Primary outcomes will include the reduction of viral load and symptom resolution within 7 days. Secondary outcomes will assess hospitalization rates, need for mechanical ventilation, and mortality. Adverse events and treatment safety will also be monitored.</p>\n<p>\n <em>Expected Outcomes:</em> The study aims to determine whether <em>Virunex-3</em> can effectively reduce symptoms and improve patient recovery while ensuring safety. If successful, this trial could contribute to the development of a new standard of care for Novacov-24 infection.</p>\n<p>\n <em>Conclusion:</em> By assessing both the effectiveness and safety of <em>Virunex-3</em>, this trial will provide valuable insights into managing Novacov-24 and preventing severe health outcomes.</p>\n
      • study_title<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • laymans_summary<p>\n This study is designed to test a new antiviral medication called <em>Virunex-3</em> to see if it can help people recover faster from an illness caused by a newly identified virus called <em>Novacov-24</em>. Participants in the study will either receive <em>Virunex-3</em> or a placebo (a pill with no active ingredients) without knowing which one they are getting. The goal is to find out if <em>Virunex-3</em> can reduce symptoms more quickly, lower the need for hospital care, and prevent serious complications. The results will help doctors understand if this new treatment is safe and effective for fighting the virus.</p>\n
      • short_titleVirunex-3 Trial for Novacov-24
      • protocol_noECCT/25/01/09 - DLoop
      • reference_no1234redwsqa
      • version_nov1
      • date_of_protocol01-01-2025
      • study_drugVirunex-3
      • disease_conditionNovacov-24 Virus Infection
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
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      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
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      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
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      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
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      • declaration_applicantOfficia quasi sunt ab ducimus eaque consectetur aut hic modi omnis
      • declaration_date110-01-2025
      • declaration_principal_investigatorCupidatat consectetur consequuntur fugiat labore necessitatibus dolore est saepe dolorem cumque aliquid aliqua In id quibusdam accusamus
      • declaration_date209-01-2025
      • protocol_not_ai_generated0
      • placebo_presentYes
      • study_objectives<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_inclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_exclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • primary_end_points<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
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      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
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      • scope_others_specifyIn odit voluptate fu
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      • trial_other_specifyVoluptas veniam ut
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      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_explanation<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_notapproved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_approved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_durationTempore id architecto quaerat ad vel
      • design_controlled_randomisedNo
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      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherYes
      • design_controlled_specifyQuo magna rerum dolor et atque adipisci esse nostrum
      • design_controlled_comparatorAut qui perspiciatis rei
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifySed iste tempore quia tempore tempor repudiandae molestias explicabo Omnis cum et asperiores vel est
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states668
      • number_of_sites9
      • multi_country_listAdipisicing et numqu
      • data_monitoring_committeeYes
      • total_enrolment_per_siteVitae voluptatem se
      • total_participants_worldwideAutem ut aut commodo quas eaque velit dolore proident adipisicing eaque lorem sunt doloribus dolor quo pariatur
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
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      • subjects_vulnerable_populationsYes
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      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
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      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyId tempora omnis vol
      • subjects_othersYes
      • subjects_others_specifyUllam laborum Eos
      • investigator1_given_nameIlliana Ferguson
      • investigator1_middle_nameAllen Fox
      • investigator1_family_nameYolanda Rivera
      • investigator1_qualificationAut labore non sed sed aut iusto et asperiores eu ut ut do qui ullam aut obcaecati earum modi in
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      • investigator1_telephone+1 (621) 831-1153
      • investigator1_emailqeryrilu@mailinator.com
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      • approval_date13-01-2025
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      • date_submitted23-01-2025
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      • ecitizen_invoice324073
      • modified2025-04-11 06:23:35
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        • given_nameHiroko Lewis
        • middle_nameTatyana Medina
        • family_nameCastor Gallagher
        • qualificationQuis molestiae voluptate aut aliquam velit est consequat Asperiores possimus et neque molestias aliqua Omnis voluptas non dolor nulla laudantium
        • professional_addressNisi qui dolor optio tempore quisquam laborum Suscipit
        • telephone+1 (322) 766-3057
        • emailtipyhuqo@mailinator.com
        • investigator_roleprincipal
        • created2025-01-13 12:13:08
        • modified2025-02-06 10:49:03
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        • contact_detailsP.O. Box 10
        • contact_personExcepturi culpa dolore vero ut blanditiis aliquam error exercitation dolore reiciendis harum molestiae molestiae magnam fugit
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        • sponsor_typeLocal Kenyan Investigator
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        • addressDolore laborum delectus dolor corrupti rerum aut magnam impedit quia cillum et cupiditate aliquid sapiente
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        • email_addresstuhokelyh@mailinator.com
        • created2025-01-13 12:13:08
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      • abstract_of_study<p>\n <em>Background:</em> The Novacov-24 virus, a newly identified respiratory pathogen, has raised global health concerns due to its rapid spread and potential for severe illness. Effective antiviral treatments are urgently needed to reduce symptom severity, prevent complications, and lower hospitalization rates.</p>\n<p>\n <em>Objective:</em> This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of <em>Virunex-3</em>, a novel antiviral agent, in reducing the severity and duration of symptoms in patients infected with the Novacov-24 virus.</p>\n<p>\n <em>Methods:</em> A total of 500 adult participants with confirmed Novacov-24 infection will be enrolled. Participants will be randomly assigned to receive either <em>Virunex-3</em> (100 mg orally, once daily for 7 days) or a placebo. Primary outcomes will include the reduction of viral load and symptom resolution within 7 days. Secondary outcomes will assess hospitalization rates, need for mechanical ventilation, and mortality. Adverse events and treatment safety will also be monitored.</p>\n<p>\n <em>Expected Outcomes:</em> The study aims to determine whether <em>Virunex-3</em> can effectively reduce symptoms and improve patient recovery while ensuring safety. If successful, this trial could contribute to the development of a new standard of care for Novacov-24 infection.</p>\n<p>\n <em>Conclusion:</em> By assessing both the effectiveness and safety of <em>Virunex-3</em>, this trial will provide valuable insights into managing Novacov-24 and preventing severe health outcomes.</p>\n
      • study_title<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • laymans_summary<p>\n This study is designed to test a new antiviral medication called <em>Virunex-3</em> to see if it can help people recover faster from an illness caused by a newly identified virus called <em>Novacov-24</em>. Participants in the study will either receive <em>Virunex-3</em> or a placebo (a pill with no active ingredients) without knowing which one they are getting. The goal is to find out if <em>Virunex-3</em> can reduce symptoms more quickly, lower the need for hospital care, and prevent serious complications. The results will help doctors understand if this new treatment is safe and effective for fighting the virus.</p>\n
      • short_titleVirunex-3 Trial for Novacov-24
      • protocol_noECCT/25/01/09 - B
      • reference_no1234redwsqa
      • version_nov1
      • date_of_protocol01-01-2025
      • study_drugVirunex-3
      • disease_conditionNovacov-24 Virus Infection
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
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      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
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      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
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      • email_addressjkiprotich@intellisoftkenya.com
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      • declaration_applicantOfficia quasi sunt ab ducimus eaque consectetur aut hic modi omnis
      • declaration_date110-01-2025
      • declaration_principal_investigatorCupidatat consectetur consequuntur fugiat labore necessitatibus dolore est saepe dolorem cumque aliquid aliqua In id quibusdam accusamus
      • declaration_date209-01-2025
      • protocol_not_ai_generated0
      • placebo_presentYes
      • study_objectives<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_inclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_exclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • primary_end_points<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
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      • scope_efficacy0
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      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others1
      • scope_others_specifyIn odit voluptate fu
      • trial_human_pharmacology0
      • trial_administration_humans1
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      • design_controlledYes
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      • staff_numbers<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_explanation<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_notapproved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_approved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_durationTempore id architecto quaerat ad vel
      • design_controlled_randomisedNo
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      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherYes
      • design_controlled_specifyQuo magna rerum dolor et atque adipisci esse nostrum
      • design_controlled_comparatorAut qui perspiciatis rei
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifySed iste tempore quia tempore tempor repudiandae molestias explicabo Omnis cum et asperiores vel est
      • single_site_member_stateNo
      • location_of_area
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      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
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      • multiple_member_states668
      • number_of_sites9
      • multi_country_listAdipisicing et numqu
      • data_monitoring_committeeYes
      • total_enrolment_per_siteVitae voluptatem se
      • total_participants_worldwideAutem ut aut commodo quas eaque velit dolore proident adipisicing eaque lorem sunt doloribus dolor quo pariatur
      • population_less_than_18_yearsYes
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      • gender_female1
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      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyId tempora omnis vol
      • subjects_othersYes
      • subjects_others_specifyUllam laborum Eos
      • investigator1_given_nameIlliana Ferguson
      • investigator1_middle_nameAllen Fox
      • investigator1_family_nameYolanda Rivera
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      • investigator1_professional_addressEst doloremque dolores adipisicing quidem laboris voluptates vitae ex
      • investigator1_telephone+1 (621) 831-1153
      • investigator1_emailqeryrilu@mailinator.com
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      • approval_date13-01-2025
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      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice324073
      • modified2025-02-13 08:07:46
      • created2025-01-22 11:13:13
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id92
        • application_id159
        • given_nameHiroko Lewis
        • middle_nameTatyana Medina
        • family_nameCastor Gallagher
        • qualificationQuis molestiae voluptate aut aliquam velit est consequat Asperiores possimus et neque molestias aliqua Omnis voluptas non dolor nulla laudantium
        • professional_addressNisi qui dolor optio tempore quisquam laborum Suscipit
        • telephone+1 (322) 766-3057
        • emailtipyhuqo@mailinator.com
        • investigator_roleprincipal
        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:46
    • SiteDetail(array)
      • 0(array)
        • id1710
        • application_id159
        • county_id38
        • site_nameAhmed Trujillo
        • physical_addressDolorum dolores necessitatibus minus magna quo velit eveniet temporibus accusantium eveniet maxime reprehenderit consectetur ipsum ea aut
        • contact_detailsP.O. Box 10
        • contact_personExcepturi culpa dolore vero ut blanditiis aliquam error exercitation dolore reiciendis harum molestiae molestiae magnam fugit
        • site_capacity(null)
        • misc(null)
        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:46
        • County(array)
          • id38
          • county_nameVihiga
          • created2012-06-15 10:26:37
          • modified2012-06-15 10:26:37
    • Sponsor(array)
      • 0(array)
        • id40
        • application_id159
        • sponsorEnim sint voluptatem eos nobis reiciendis dolore et qui corrupti quod minim pariatur Possimus
        • sponsor_typeLocal Kenyan Investigator
        • contact_personDolorem mollitia id quis provident error voluptatem voluptate
        • addressDolore laborum delectus dolor corrupti rerum aut magnam impedit quia cillum et cupiditate aliquid sapiente
        • telephone_number+1 (666) 325-1183
        • fax_number+1 (314) 248-5575
        • cell_number+1 (134) 102-6236
        • email_addresstuhokelyh@mailinator.com
        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:46
    • PublicAction(array)
      • labelApproved
      • date13-01-2025
  • 8(array)
    • Application(array)
      • id158
      • user_id86
      • application_id118
      • is_child1
      • trial_status_id7
      • trial_status_date(null)
      • total_sites5
      • abstract_of_study<p>\n <em>Background:</em> The Novacov-24 virus, a newly identified respiratory pathogen, has raised global health concerns due to its rapid spread and potential for severe illness. Effective antiviral treatments are urgently needed to reduce symptom severity, prevent complications, and lower hospitalization rates.</p>\n<p>\n <em>Objective:</em> This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of <em>Virunex-3</em>, a novel antiviral agent, in reducing the severity and duration of symptoms in patients infected with the Novacov-24 virus.</p>\n<p>\n <em>Methods:</em> A total of 500 adult participants with confirmed Novacov-24 infection will be enrolled. Participants will be randomly assigned to receive either <em>Virunex-3</em> (100 mg orally, once daily for 7 days) or a placebo. Primary outcomes will include the reduction of viral load and symptom resolution within 7 days. Secondary outcomes will assess hospitalization rates, need for mechanical ventilation, and mortality. Adverse events and treatment safety will also be monitored.</p>\n<p>\n <em>Expected Outcomes:</em> The study aims to determine whether <em>Virunex-3</em> can effectively reduce symptoms and improve patient recovery while ensuring safety. If successful, this trial could contribute to the development of a new standard of care for Novacov-24 infection.</p>\n<p>\n <em>Conclusion:</em> By assessing both the effectiveness and safety of <em>Virunex-3</em>, this trial will provide valuable insights into managing Novacov-24 and preventing severe health outcomes.</p>\n
      • study_title<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • laymans_summary<p>\n This study is designed to test a new antiviral medication called <em>Virunex-3</em> to see if it can help people recover faster from an illness caused by a newly identified virus called <em>Novacov-24</em>. Participants in the study will either receive <em>Virunex-3</em> or a placebo (a pill with no active ingredients) without knowing which one they are getting. The goal is to find out if <em>Virunex-3</em> can reduce symptoms more quickly, lower the need for hospital care, and prevent serious complications. The results will help doctors understand if this new treatment is safe and effective for fighting the virus.</p>\n
      • short_titleVirunex-3 Trial for Novacov-24
      • protocol_noECCT/25/01/09 - A
      • reference_no1234redwsqa
      • version_nov1
      • date_of_protocol01-01-2025
      • study_drugVirunex-3
      • disease_conditionNovacov-24 Virus Infection
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantOfficia quasi sunt ab ducimus eaque consectetur aut hic modi omnis
      • declaration_date110-01-2025
      • declaration_principal_investigatorCupidatat consectetur consequuntur fugiat labore necessitatibus dolore est saepe dolorem cumque aliquid aliqua In id quibusdam accusamus
      • declaration_date209-01-2025
      • protocol_not_ai_generated0
      • placebo_presentYes
      • study_objectives<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_inclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_exclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • primary_end_points<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others1
      • scope_others_specifyIn odit voluptate fu
      • trial_human_pharmacology0
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyVoluptas veniam ut
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_explanation<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_notapproved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_approved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_durationTempore id architecto quaerat ad vel
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherYes
      • design_controlled_specifyQuo magna rerum dolor et atque adipisci esse nostrum
      • design_controlled_comparatorAut qui perspiciatis rei
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifySed iste tempore quia tempore tempor repudiandae molestias explicabo Omnis cum et asperiores vel est
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites6
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteVitae voluptatem se
      • total_participants_worldwideAutem ut aut commodo quas eaque velit dolore proident adipisicing eaque lorem sunt doloribus dolor quo pariatur
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyId tempora omnis vol
      • subjects_othersYes
      • subjects_others_specifyUllam laborum Eos
      • investigator1_given_nameIlliana Ferguson
      • investigator1_middle_nameAllen Fox
      • investigator1_family_nameYolanda Rivera
      • investigator1_qualificationAut labore non sed sed aut iusto et asperiores eu ut ut do qui ullam aut obcaecati earum modi in
      • investigator1_professional_addressEst doloremque dolores adipisicing quidem laboris voluptates vitae ex
      • investigator1_telephone+1 (621) 831-1153
      • investigator1_emailqeryrilu@mailinator.com
      • organisations_transferred_Yes
      • number_participantsMinim dolor commodo
      • notification
      • approval_date13-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-01-2025
      • unsubmitted1
      • initial_date_submitted22-01-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThis is approved
      • approved_date(null)
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice324073
      • modified2025-02-13 08:07:31
      • created2025-01-22 10:39:23
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id91
        • application_id158
        • given_nameHiroko Lewis
        • middle_nameTatyana Medina
        • family_nameCastor Gallagher
        • qualificationQuis molestiae voluptate aut aliquam velit est consequat Asperiores possimus et neque molestias aliqua Omnis voluptas non dolor nulla laudantium
        • professional_addressNisi qui dolor optio tempore quisquam laborum Suscipit
        • telephone+1 (322) 766-3057
        • emailtipyhuqo@mailinator.com
        • investigator_roleprincipal
        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:31
    • SiteDetail(array)
      • 0(array)
        • id128
        • application_id158
        • county_id42
        • site_nameMiranda Alvarez
        • physical_addressAut ad quasi commodi non sint libero enim eos consequatur corrupti harum non
        • contact_detailsP.O. Box 86856
        • contact_personVoluptatibus molestias eligendi non repudiandae quis ipsa minim quia nostrum ut nisi possimus veniam
        • site_capacity(null)
        • misc(null)
        • created2013-06-27 10:49:32
        • modified2025-02-13 08:07:31
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id39
        • application_id158
        • sponsorEnim sint voluptatem eos nobis reiciendis dolore et qui corrupti quod minim pariatur Possimus
        • sponsor_typeLocal Kenyan Investigator
        • contact_personDolorem mollitia id quis provident error voluptatem voluptate
        • addressDolore laborum delectus dolor corrupti rerum aut magnam impedit quia cillum et cupiditate aliquid sapiente
        • telephone_number+1 (666) 325-1183
        • fax_number+1 (314) 248-5575
        • cell_number+1 (134) 102-6236
        • email_addresstuhokelyh@mailinator.com
        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:31
    • PublicAction(array)
      • labelApproved
      • date13-01-2025
  • 9(array)
    • Application(array)
      • id2
      • user_id29
      • application_id(null)
      • is_child0
      • trial_status_id4
      • trial_status_date2024-02-29 09:07:33
      • total_sites2
      • abstract_of_study<p>\n Abstract</p>\n
      • study_title<p>\n Sample Title</p>\n
      • laymans_summary<p>\n Some Summary</p>\n
      • short_titleShort Title
      • protocol_noECCT/24/01/01
      • reference_no(null)
      • version_nov12
      • date_of_protocol09-01-2024
      • study_drugName
      • disease_conditionSome condition
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals1
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_namechemical name
      • product_type_medical_device_namemedical device
      • comparatorYes
      • comparator_nameSome
      • comparator_registeredSome
      • comparator_countriesSome
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantsome
      • declaration_date109-01-2024
      • declaration_principal_investigatorsome
      • declaration_date209-01-2024
      • protocol_not_ai_generated0
      • placebo_presentNo
      • study_objectives<p>\n objectives</p>\n
      • principal_inclusion_criteria<p>\n inclusion</p>\n
      • principal_exclusion_criteria<p>\n exclusion</p>\n
      • primary_end_points<p>\n end points</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence1
      • scope_dose_response1
      • scope_pharmacogenetic1
      • scope_pharmacogenomic1
      • scope_pharmacoecomomic1
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n some capacity</p>\n
      • other_details_explanation<p>\n some</p>\n
      • other_details_regulatory_notapproved<p>\n some</p>\n
      • other_details_regulatory_approved<p>\n some</p>\n
      • other_details_regulatory_rejected<p>\n some</p>\n
      • other_details_regulatory_halted<p>\n some</p>\n
      • estimated_duration3some
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listsome four states here
      • data_monitoring_committeeYes
      • total_enrolment_per_site30
      • total_participants_worldwide50
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifysome
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namesome
      • investigator1_middle_namesome
      • investigator1_family_namesome
      • investigator1_qualificationsome
      • investigator1_professional_addresssome
      • investigator1_telephone254700234871
      • investigator1_emailsample@gmail.com
      • organisations_transferred_No
      • number_participants20
      • notification<p>\n None</p>\n
      • approval_date13-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-05-2024
      • unsubmitted1
      • initial_date_submitted22-05-2024
      • admin_stopped1
      • admin_stopped_reasonVillation
      • approved2
      • approved_reasonHey
      • approved_date(null)
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice301439
      • modified2025-02-13 09:04:41
      • created2024-01-09 05:09:48
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id2
        • application_id2
        • given_namesome name principal
        • middle_namesome name principal
        • family_namesome name principal
        • qualificationsome qualofication
        • professional_addresssome address
        • telephone254700282716
        • emailsome@gmail.com
        • investigator_roleprincipal
        • created2024-01-09 05:37:44
        • modified2024-06-25 08:22:28
    • SiteDetail(array)
      • 0(array)
        • id1639
        • application_id2
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2024-01-09 05:37:44
        • modified2024-06-25 08:22:28
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id14
        • application_id2
        • sponsorsome sponsor
        • sponsor_typeIndustry
        • contact_personsome contact person
        • addressaddress
        • telephone_number0700432422
        • fax_number
        • cell_number0700434343
        • email_addresssponsor@gmail.com
        • created2024-05-22 16:52:09
        • modified2024-06-25 08:22:28
    • PublicAction(array)
      • labelApproved
      • date13-01-2025
• page_options(array)
  • 1010
  • 5050
  • 100100
• redir
• $request->data(array)
  • Application(array)
    • statusapproved
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/ctr/lib
• 3/usr/share/php
• 4-> /var/www/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php