Novel Coronavirus Pneumonia
Conditions
Interventions
Experimental group:Azvudine(FNC) and symptomatic treatment (except antiviral treatment)
Control group:Antiviral therapy and symptomatic treatment
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years(including cut-off value), gender not limited; 2. Sputum/nasal swabs/pharyngeal swabs/lower respiratory tract secretions and other specimens, RT-PCR detected the new coronavirus nucleic acid positive, or the viral gene sequencing was highly homologous with the known Delta virus; 3. Patients diagnosed with novel coronavirus meet the diagnostic criteria of the pneumonia diagnosis and treatment program for novel coronavirus infection issued by National Health Commission of China; 4. Informed consent has been signed.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergies to the components of azivudine tablets; 2. 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; 3. Participating in other clinical trials or using experimental drugs within 12 weeks before administration; 4. Other conditions that not appropriate to be enrolled into this study based on investigator's advise.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time and rate 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;Time and rate of improvement in pulmonary imaging;Novel coronavirus nucleic acid negative conversion time and proportion;Time and rate of improvement of oxygenation measurement;Improvement time and rate of CD4 count;Rate of mild/modorate type to severe type, rate of severe type to critical type;Length of hospitalization;Mortality;Vital signs (body temperature, heart rate, breathing, blood pressure);Blood routine, erythrocyte sedimentation rate, C-reactive protein, liver function, kidney function, coagulation function, myocardial enzyme spectrum, myocardial markers, T lymphocyte subsets, pregnancy test;Electrocardiogram;Adverse events: including type, incidence, severity, time, and drug relevance; | — |
Countries
China
Contacts
Public ContactYu Zujiang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed