Official Title
A Randomized,Double Blinded, Double Dummy, Parallel Controlled Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19)
Brief Summary

To evaluate the efficacy and safety of azvudine in treatment of COVID-19

Unknown status
COVID-19

Drug: FNC+Standard of Care

FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
Other Name: Azvudine+SOC

Drug: FNC dummy tablet+Standard of Care

FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
Other Name: Azvudin dummy tablet+SOC

Eligibility Criteria

Inclusion Criteria:

1. age ≥18 years old, gender not limited;

2. Laboratory (RT-PCR) confirmed COVID-19;

3. the time from the first positive nucleic acid test to randomization does not exceed
more than 4 days;

4. informed consent has been signed.

Exclusion Criteria:

1. known or suspected allergies to the components of azivudine tablets;

2. 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;

3. severe liver disease (TBIL>=2 times normal upper limit; ALTAST>=5 times normal upper
limit);

4. subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73
m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal
dialysis;

5. subjects with complication of malabsorption syndrome or any other condition affecting
gastrointestinal absorption, requiring intravenous nutrition or not being able to take
drugs orally;

6. subjectsis currently receiving anti-hiv treatment;

7. 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;

8. participating in other clinical trials or using experimental drugs, except traditional
Chinese medicine;

9. Other conditions that not appropriate to be enrolled into this study based on
investigator's advise.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 99 Years
HeNan Sincere Biotech Co., Ltd
NCT Number
MeSH Terms
COVID-19
Pneumonia