Pharmacy and Poisons Board
Protocol No: ECCT/25/01/09 - B Date of Protocol: 01-01-2025
Study Title:

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
Study Objectives:

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
Laymans Summary:

This study is designed to test a new antiviral medication called Virunex-3 to see if it can help people recover faster from an illness caused by a newly identified virus called Novacov-24. Participants in the study will either receive Virunex-3 or a placebo (a pill with no active ingredients) without knowing which one they are getting. The goal is to find out if Virunex-3 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.
Abstract of Study:

Background: 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.

Objective: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of Virunex-3, a novel antiviral agent, in reducing the severity and duration of symptoms in patients infected with the Novacov-24 virus.

Methods: A total of 500 adult participants with confirmed Novacov-24 infection will be enrolled. Participants will be randomly assigned to receive either Virunex-3 (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.

Expected Outcomes: The study aims to determine whether Virunex-3 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.

Conclusion: By assessing both the effectiveness and safety of Virunex-3, this trial will provide valuable insights into managing Novacov-24 and preventing severe health outcomes.