Clinical trial NCT04425772: A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）
Official title: A Randomized,Double Blinded, Double Dummy, Parallel Controlled Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Henan Genuine Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change (reduction) in viral load from baseline
timeFrame: On day 7 and 14
Secondary outcomes:
measure: proportion of subjects change from mild or moderate type to severe type
timeFrame: up to 21 days
measure: proportion of subjects change from severe type to critical type
timeFrame: up to 21 days
measure: novel coronavirus nucleic acid conversion rate
timeFrame: up to 21 days
measure: Novel coronavirus nucleic acid negative conversion time
timeFrame: up to 21 days
measure: The time and proportion of improvement in pulmonary imaging
timeFrame: up to 21 days
measure: Time and proportion of temperature return to normal
timeFrame: up to 21 days
measure: time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)
timeFrame: up to 21 days
measure: time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms
timeFrame: up to 21 days
measure: Changes of blood oxygen detection index
timeFrame: up to 21 days
measure: Frequency of requirement for supplemental oxygen or non-invasive ventilation
timeFrame: up to 21 days
measure: Frequency of adverse events
timeFrame: up to 21 days
Other outcomes:
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