COVID-19
Conditions
Brief summary
To evaluate the efficacy and safety of azvudine in treatment of COVID-19
Interventions
DRUGFNC+Standard of Care
FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
DRUGFNC 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
Sponsors
Henan Genuine Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change (reduction) in viral load from baseline | On day 7 and 14 | (reduction) in viral load from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of subjects change from severe type to critical type | up to 21 days | proportion of subjects change from severe type to critical type |
| novel coronavirus nucleic acid conversion rate | up to 21 days | novel coronavirus nucleic acid conversion rate |
| Novel coronavirus nucleic acid negative conversion time | up to 21 days | Novel coronavirus nucleic acid negative conversion time |
| The time and proportion of improvement in pulmonary imaging | up to 21 days | TIme(Days);Proportion(percent) |
| Time and proportion of temperature return to normal | up to 21 days | TIme(Days);Proportion(percent) |
| proportion of subjects change from mild or moderate type to severe type | up to 21 days | proportion of subjects change from mild or moderate type to severe type |
| time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms | up to 21 days | TIme(Days);Proportion(percent) |
| Changes of blood oxygen detection index | up to 21 days | Changes of blood oxygen detection index |
| Frequency of requirement for supplemental oxygen or non-invasive ventilation | up to 21 days | Frequency of requirement for supplemental oxygen or non-invasive ventilation |
| Frequency of adverse events | up to 21 days | Frequency of adverse events |
| time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.) | up to 21 days | TIme(Days);Proportion(percent) |
Outcome results
None listed