Study of Azvudine Compared to Placebo in Adults with COVID-19 at High Risk of Severe Illness

What this Trial Is About

Researchers are evaluating whether Azvudine can reduce the risk of severe illness or death in adults with COVID-19 who are at higher risk of progressing to severe infection. This randomized, double-blind, placebo-controlled trial aims to compare the effects of Azvudine plus conventional therapy versus placebo plus conventional therapy in symptomatic adults. The study is sponsored by Peking Union Medical College Hospital and includes participants who meet specific risk factors for severe COVID-19. Participants will be randomly assigned in a 11 ratio to receive either Azvudine or a placebo, both given orally at a dose of 5 mg daily for up to 7 days, alongside conventional therapy excluding antiviral treatments. The trial plans to enroll 548 participants in each group and monitor them closely for efficacy and safety during the treatment period. Throughout the study, participants will be assessed for the proportion who develop critical illness or die within 28 days. Researchers will also monitor adverse events, symptom duration, viral load at days 1, 3, and 7, hospitalization and ICU stay lengths, and all-cause mortality up to 6 months. Safety follow-up will be conducted, and participants health status will be regularly evaluated using clinical and laboratory measures.

Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 at Increased Risk of Progressing to Severe Illness