Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental Group:FNC+Standard of Care
Control Group:FNC dummy tablet+ Standard of Care
Sponsors
Beijing Ditan Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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 |
|---|---|
| On day 7 and 14, Change (reduction) in viral load from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of subjects change from mild or moderate type to severe type;proportion of subjects change from severe type to critical type;on days 7, 14 and 21, novel coronavirus nucleic acid conversion rate;Novel coronavirus nucleic acid negative conversion time;The time and proportion of improvement in pulmonary imaging;Time and proportion of temperature return to normal;time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.);time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms;Changes of blood oxygen detection index;Frequency of requirement for supplemental oxygen or non-invasive ventilation;Frequency of adverse events; | — |
Countries
China
Contacts
Public ContactZhang Fujie
Outcome results
None listed