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To evaluate the efficacy and safety of azvudine in treatment of COVID-19
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | FNC+Standard of Care |
|
| Control Group | Placebo Comparator | FNC dummy tablet+ Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FNC+Standard of Care | Drug | FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change (reduction) in viral load from baseline | (reduction) in viral load from baseline | On day 7 and 14 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| FNC dummy tablet+Standard of Care | Drug | FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria |
|
|
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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |