At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 1,096 target
Drug / intervention
Azvudine +1 moredrug
Likely dose
Azvudine 5mgfrom record
Key inclusion· 5
- ✓Age 18 years or older
- ✓Symptoms of COVID-19 within 5 days and positive nucleic acid or antigen test within 5 days before enrollment
- ✓At least one COVID-19 symptom present at enrollment
- ✓Agreement to practice effective birth control for females of child-bearing potential
Key exclusion· 13
- ✕Known or suspected allergy to Azvudine Tablets components
- ✕Severe or critical COVID-19 infection
- ✕Severe liver disease with TBIL ≥2× ULN or ALT/AST ≥3× ULN
- ✕Severe renal insufficiency with GFR ≤60 mL/min/1.73 m² or on continuous renal replacement therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05689034Phase 3RecruitingUpdate OverdueUpdated 19mo ago · Completion was 12mo agoEnrollment Stalled
Long Recruiting
Update Overdue
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
In Brief
A Phase 3 clinical trial evaluating Azvudine and Placebo for COVID-19 Respiratory Infection. Currently recruiting, targeting 1,096 participants across 1 site.
Signals
Enrollment appears stalled
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19 Respiratory Infection
CountriesChina
Collaborators--
Timeline
Phase 3RecruitingOverdue
2023202420252026
First PostedJan 2023
Enrollment StartApr 2023
Primary CompletionJun 2025
Study CompletionDec 2025
TodayJul 2026
First PostedJan 18, 2023
Enrollment StartApr 19, 2023
Primary CompletionJun 30, 2025
Study CompletionDec 31, 2025
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 3.5 years ago
Interventions
Azvudinedrug
Azvudine po. 5mg daily for 7 days
Placebodrug
Placebo po. 5 tablets daily for 7 days