NCT05689034

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

A Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adult Participants With COVID-19 Who Are at Increased Risk of Progressing to Severe Illness

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,096 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

To investigate whether treatment with Azvudine reduces the risk of severe illness or death in patients who are at a potential risk of progressing to severe COVID-19 infection.

Detailed description

The study is designed as a randomized, parallel, double-blind, placebo-controlled trial, in which all participants will be randomized to a test group or control group in a 1:1 ratio. The test group will be given Azvudine in combination with conventional therapy excluding anti-viral therapy and observed for efficacy. The control group will be given placebo in combination with conventional therapy excluding anti-viral therapy and observed for efficacy. Test Group will recruit 548 participants who will be given Azvudine + conventional therapy other than antiviral\*5 mg/day, oral, up to 7 days (1 mg/tablet). Control Group will recruit 548 who will be given Placebo + conventional therapy other than antiviral\* 5 tablets/day, oral, up to 7 days.

Conditions

• COVID-19 Respiratory Infection

Interventions

Type	Name	Description
DRUG	Azvudine	Azvudine po. 5mg daily for 7 days
DRUG	Placebo	Placebo po. 5 tablets daily for 7 days

Timeline

• Start date: 2023-04-19
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2023-01-18
• Last updated: 2024-11-25

Locations

1 site across 1 country: China