Actively Recruiting
Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 at Increased Risk of Progressing to Severe Illness
Led by Peking Union Medical College Hospital · Updated on 2024-11-25
1096
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 at Increased Risk of Progressing to Severe Illness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- COVID-19 symptoms started within the last 5 days
- Positive nucleic acid or antigen test for COVID-19 within 5 days before enrollment
- At least one COVID-19 symptom present at enrollment
- Agreement to use effective birth control (for females of child-bearing potential)
- Presence of at least one high risk factor for severe COVID-19, including age 60 or older, BMI over 25, fever of 386C or higher for at least 3 days, current smoker, immunosuppressive diseases or treatments, chronic lung disease, hypertension, cardiovascular diseases, diabetes, neurodevelopmental abnormalities, active tumors (excluding localized skin cancer), or no COVID-19 vaccination
You will not qualify if you...
- Known or suspected allergy to Azvudine components
- Diagnosis of severe or critical COVID-19 infection
- Severe liver disease (e.g., high bilirubin or liver enzymes)
- Severe kidney failure or receiving dialysis
- Malabsorption syndrome or difficulty taking oral medication
- Known HIV infection
- Diabetic ketosis or hyperosmolar hyperglycemic state
- Low neutrophil count (<750 cells/L)
- Pregnant, lactating, or planning pregnancy during study and 6 months after
- Participation in another clinical trial or use of another investigational product
- Other active infections besides COVID-19
- Comorbidities requiring hospitalization or surgery recently or life-threatening within 30 days
- Received or expected to receive convalescent plasma for COVID-19
- Previous treatment with proven effective antiviral agents against COVID-19 (except glucocorticoids for other reasons)
- Any other condition making participation inappropriate per investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
X
Xinlun Tian
CONTACT
M
Mengzhao Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here