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• controllerapplications
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• named(array)
  • page1
  • sortprotocol_no
  • directiondesc
  • trial_therapeutic_confirmatory1
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        • Application.protocol_nodesc
      • sortprotocol_no
      • directiondesc
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• Application(array)
  • trial_therapeutic_confirmatory1

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• 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  • 9Application withdrawn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
• applications(array)
  • 0(array)
    • Application(array)
      • id248
      • user_id29
      • application_id(null)
      • is_child0
      • trial_status_id(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
      • 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
  • 1(array)
    • Application(array)
      • id118
      • user_id29
      • application_id(null)
      • is_child0
      • trial_status_id7
      • 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- 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
      • 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
      • 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
      • 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
      • modified2025-02-14 10:11:54
      • created2024-10-17 10:21:33
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id87
        • 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
    • SiteDetail(array)
      • 0(array)
        • id1707
        • application_id118
        • 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
        • modified2025-02-06 10:49:58
        • County(array)
          • id38
          • county_nameVihiga
          • created2012-06-15 10:26:37
          • modified2012-06-15 10:26:37
    • Sponsor(array)
      • 0(array)
        • id36
        • application_id118
        • 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
        • modified2025-02-06 10:49:58
  • 2(array)
    • Application(array)
      • id160
      • user_id89
      • application_id118
      • is_child1
      • trial_status_id(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 - 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
      • 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
      • 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_submitted23-01-2025
      • unsubmitted1
      • initial_date_submitted23-01-2025
      • 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
      • modified2025-04-11 06:23:35
      • created2025-01-23 08:22:01
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id93
        • application_id160
        • 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
    • SiteDetail(array)
      • 0(array)
        • id1711
        • application_id160
        • 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
        • modified2025-02-06 10:49:03
        • County(array)
          • id38
          • county_nameVihiga
          • created2012-06-15 10:26:37
          • modified2012-06-15 10:26:37
    • Sponsor(array)
      • 0(array)
        • id41
        • application_id160
        • 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
        • modified2025-02-06 10:49:03
  • 3(array)
    • Application(array)
      • id159
      • user_id86
      • application_id118
      • is_child1
      • trial_status_id(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 - 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
      • 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
      • 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
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      • 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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      • number_participantsMinim dolor commodo
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      • approval_date13-01-2025
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      • admin_stopped0
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      • ecitizen_invoice324073
      • modified2025-02-13 08:07:46
      • created2025-01-22 11:13:13
      • ai_content(null)
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        • 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
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        • application_id159
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        • site_nameAhmed Trujillo
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        • contact_detailsP.O. Box 10
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        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:46
        • County(array)
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          • county_nameVihiga
          • created2012-06-15 10:26:37
          • modified2012-06-15 10:26:37
    • Sponsor(array)
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        • id40
        • application_id159
        • sponsorEnim sint voluptatem eos nobis reiciendis dolore et qui corrupti quod minim pariatur Possimus
        • 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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        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:46
  • 4(array)
    • Application(array)
      • id158
      • user_id86
      • application_id118
      • is_child1
      • trial_status_id7
      • 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
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      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
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      • applicant_participating_countries(null)
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      • applicant_fees1
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      • 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
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      • 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
      • 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
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      • initial_date_submitted22-01-2025
      • admin_stopped0
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      • approved_reasonThis is approved
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      • 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
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_therapeutic_confirmatory1
• $this->validationErrors(array)
  • Permission(empty)
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  • InvestigatorContact(empty)
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  • SiteDetail(empty)
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  • 1Form
  • 2Session
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  • 5SimpleGraph
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  • 8Toolbar
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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

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• app(array)
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