Novel coronavirus infection (COVID-19)
Conditions
Interventions
COVID-19 patients treated with deuterated remidevir hydrobromide tablets:None
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. SARS-CoV-2 infection (COVID-19), meeting at least one of the following five criteria: Diagnosed with SARS-CoV-2 infection; Diagnosed with COVID-19 pneumonia; Positive SARS-CoV-2 nucleic acid test; Positive SARS-CoV-2 antigen test; Positive SARS-CoV-2 viral culture.
Exclusion criteria
Exclusion criteria: 1. Patients with severe or critical COVID-19; 2. Requiring or anticipated to urgently require mechanical ventilation; 3. Known hypersensitivity to any ingredient in the study drug formulation; 4. Any medical condition that, in the opinion of the investigator, would jeopardize subject safety; 5. Pregnant women;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of COVID-19 disease progression events as of day 28 (including the rate of COVID-19-related hospitalization in non-hospitalized subjects, the incidence of progression to severe COVID-19, the incidence of progression to critical COVID-19, and all-cause mortality); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to sustained resolution of clinical symptoms (the first day of 2 consecutive days with symptom;Percentage of participants with SARS-CoV-2 nucleic acid negative conversion by Day 28;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactLi Feng
Shanghai Public Health Clinical Center
Outcome results
None listed