COVID-19
Conditions
Interventions
low-dose group:D1:400mgQ12h, D2-D5:200 mg Q12h
high-dose group:D1:600mgQ12h, D2-D5:300 mg Q12h
Sponsors
The Third People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old =65 years old, male or female; 2. The subject's SARS-CoV-2 nucleic acid test result is positive and meets the following conditions: 1) Less than 3 days after the first positive SARS-CoV-2 virus infection was detected; 2) Ct value of SARS-CoV-2 virus nucleic acid detection in baseline period =25; 3. At the time of screening, pregnancy tests were negative for women of reproductive age who had not undergone surgical sterilization or for women less than 1 year after menopause. Male and female subjects of reproductive age agreed to use effective contraception for 6 months after the trial medication; 4. Voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed as severe or critical according to the "COVID-19 Diagnosis and Treatment Protocol (Trial version 9)"; 2. Receiving or previously receiving specific monoclonal/polyclonal antibodies against SARS-CoV-2, anti-SARS-CoV-2 antiviral drugs/or previously receiving plasma (convalescent plasma) from patients recovering from COVID-19; 3. TCM products recommended by "COVID-19 Diagnosis and Treatment Protocol (Trial version 9)"; 4. At the time of screening, patients were receiving more than 20mg/ day equivalent dose of prednisone steroid or long-term (more than 10 days) intravenous immunoglobulin, systemic steroid, interleukin-1 inhibitor, interleukin-6 inhibitor and other immunosuppressive therapy (except for topical skin use); 5. Patients with severe active bacterial, fungal, viral infection (except COVID-19), severe immunodeficiency disease (such as HIV infection), or other systemic serious underlying diseases judged by the investigator not suitable for inclusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 RNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactLu Hongzhou
The Third People's Hospital of Shenzhen
Outcome results
None listed