A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of azvudine in treatment of COVID-19

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: FNC+Standard of Care
* Drug: FNC dummy tablet+Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>FNC+Standard of Care | Drug: FNC+Standard of Care<br>* FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria<br>* Other names: Azvudine+SOC;|
| Placebo Comparator: Control Group<br>FNC dummy tablet+ Standard of Care | Drug: FNC dummy tablet+Standard of Care<br>* FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria<br>* Other names: Azvudin dummy tablet+SOC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (reduction) in viral load from baseline | (reduction) in viral load from baseline | On day 7 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of subjects change from mild or moderate type to severe type | proportion of subjects change from mild or moderate type to severe type | up to 21 days | 
| proportion of subjects change from severe type to critical type | proportion of subjects change from severe type to critical type | up to 21 days | 
| novel coronavirus nucleic acid conversion rate | novel coronavirus nucleic acid conversion rate | up to 21 days | 
| Novel coronavirus nucleic acid negative conversion time | Novel coronavirus nucleic acid negative conversion time | up to 21 days | 
| The time and proportion of improvement in pulmonary imaging | TIme(Days);Proportion(percent) | up to 21 days | 
| Time and proportion of temperature return to normal | TIme(Days);Proportion(percent) | up to 21 days | 
| time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.) | TIme(Days);Proportion(percent) | up to 21 days | 
| time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms | TIme(Days);Proportion(percent) | up to 21 days | 
| Changes of blood oxygen detection index | Changes of blood oxygen detection index | up to 21 days | 
| Frequency of requirement for supplemental oxygen or non-invasive ventilation | Frequency of requirement for supplemental oxygen or non-invasive ventilation | up to 21 days | 
| Frequency of adverse events | Frequency of adverse events | up to 21 days |