Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
test group:Azvudine
Sponsors
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects must be at least 18 years old; 2. Subjects have positive SARS-CoV-2 test results; 3. The subject has one or more mild or moderate COVID-19 clinical symptoms, and the symptom score is = 2 points: fever, cough, sore throat, nasal congestion or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or dyspnea, chills or chills; 4. The first occurrence of COVID-19 symptoms is more than 5 days from the first administration of the trial drug; 5. It is necessary to meet one or more of the following high-risk factors that progress to severe COVID-19 (including death): 1) Age = 60 years old; 2) Coronary heart disease or hypertension; 3) Cerebral infarction or nervous system disease (Alzheimer's disease or Parkinson's disease); 4) Chronic obstructive pulmonary disease or interstitial pulmonary disease or pulmonary hypertension; 5) Diabetes; 6) The patient has immunosuppressive disease or is receiving immunosuppressive treatment; 7) Obesity or overweight BMI>25 kg/m2; 8) Chronic liver disease or kidney disease; 9) Cancer;
Exclusion criteria
Exclusion criteria: 1. SpO2 = 93% or PaO2/FiO2 = 300, or respiratory rate = 30/min in indoor air at sea level; 2. Mechanical ventilation is required; 3. Subjects have received SARS-CoV-2 monoclonal antibody treatment or preventive or antiviral treatment (including research treatment); 4. Subjects have received COVID-19 plasma treatment in recovery period;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to sustained clinical recovery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of the participants died from any cause through Day 28;The average hospitalization time;The average hospitalization expenses;The changes in liver and kidney function during oral medication;Adverse events; | — |
Countries
China
Contacts
Public ContactXingguang Wang
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed