Status:
UNKNOWN
A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）
Lead Sponsor:
Henan Genuine Biotech Co., Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
To evaluate the efficacy and safety of azvudine in treatment of COVID-19
Eligibility Criteria
Inclusion
- age ≥18 years old, gender not limited;
- Laboratory (RT-PCR) confirmed COVID-19;
- the time from the first positive nucleic acid test to randomization does not exceed more than 4 days;
- informed consent has been signed.
Exclusion
- known or suspected allergies to the components of azivudine tablets;
- according to the latest version of the National Health and Medical Commission Diagnostic criteria of COVID-19, patients with severe novel coronavirus pneumonia was confirmed;
- severe liver disease (TBIL\>=2 times normal upper limit; ALTAST\>=5 times normal upper limit);
- subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
- subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally;
- subjectsis currently receiving anti-hiv treatment;
- women who are breast-feeding during pregnancy or have a family plan during the trial period and within 6 months after the end of the trial;
- participating in other clinical trials or using experimental drugs, except traditional Chinese medicine;
- Other conditions that not appropriate to be enrolled into this study based on investigator's advise.
Key Trial Info
Start Date :
June 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 12 2020
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT04425772
Start Date
June 12 2020
End Date
August 12 2020
Last Update
June 11 2020
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