COVID-19
Conditions
Interventions
Leritvir tablets group:None
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent before the study, and fully understand the research content, process and possible adverse reactions; 2. Age 18 (inclusive) or above, gender unlimited; 3. Confirmed mild and moderate COVID-19 patients;
Exclusion criteria
Exclusion criteria: 1. During the course of the disease, she had received other small-molecule oral drugs for the treatment of COVID-19 infection before seeing a doctor; 2. Patients with severe kidney injury (Ccr<30 mL/min); 3. Patients suffering from mental disorders; 4. Coma, dysphagia patients; 5. Obvious abnormal liver function at screening (ALT or AST=10ULN); 6. Patients with uncontrolled HIV-1 infection; 7. Those who were vaccinated within 28 days before enrollment and planned to be vaccinated during the study period; 8. Pregnant or lactating women or pregnancy test positive; 9. Participants participating in and receiving other clinical trial drugs within 1 month before medication; 10. Other conditions deemed unsuitable for inclusion by the doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of recovery from clinical symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Admission rate;Proportion of subjects converted to severe or critical clinical classification;Mortality rate;WHO clinical progress Scale score on day 2, 5 and 10 after medication increased the proportion of subjects;2 days, 5 days, 10 days after medication, nucleic acid conversion rate (more than 24 hours between two nucleic acid detection Ct=35);Symptom recovery rate at day 2, day 5, day 10, day 14, day 28 after medication;Time of first negative nucleic acid transition;Time of first negative antigen conversion and negative conversion rate at each detection time point;Proportion of aggravation in clinical classification;Changes in viral load from baseline;Baseline virus typing and drug resistance mutation analysis;Routine blood test;Liver and kidney function;Coagulation function;Inflammatory marker; | — |
Countries
China
Contacts
Public ContactJianxing He
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed