mild to moderate COVID-19
Conditions
Interventions
Test group:GST-HG171 tablets combined with ritonavir
Placebo group: Placebo
Sponsors
The First Affiliated Hospital of Guangzhou Medical University;The Third People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants =18 years of age. 2.Confirmed SARS-CoV-2 infection 4 days prior to randomization. 3.The subjects were classified as mild/moderate type COVID-19. 4.Initial onset 2 of 11 COVID-19 symptoms within 48 hours before randomization,respiratory and feverish symptoms must be included. 5.Participants who are willing and able to comply with the protocol for treatment plan, virological testing, laboratory testing and other study procedures. 6.Fertile participants must agree to take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1.Has hypersensitivity or other contraindication to any of the components of the study interventions; 2.Patients with severe or critical COVID-19; 3.Active liver disease, or obvious abnormal liver function (ALT or AST = 3ULN, or total bilirubin = 1.5ULN); 4.Receiving dialysis or have known moderate to severe renal impairment; 5.Compromised immune system; 6.Acute episode of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease; 7.Suspected or confirmed concurrent active systemic infection other than COVID-19; 8.Any comorbidity requiring surgery within 14 days prior to study entry, or that is considered life-threatening within 30 days prior to study entry, as determined by the investigator; 9.Treatment with antivirals against SARS-CoV-2 within 14 days prior to randomization; 10.Current or expected use of strong CYP3A4 inducers, inhibitors or medications that are highly dependent on CYP3A4 for clearance; 11.Has received or is expected to receive COVID-19 monoclonal antibody or convalescent COVID-19 plasma during study treatment; 12.Has received any SARS-CoV-2 vaccine within 3 months prior to randomization; 13.Previous administration with any investigational drug within 3 months before the study drug administration; 14.Pregnant, lactating women or those with a positive pregnancy test; 15.Participants who are judged by the investigator to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to sustained clinical recovery of 11 COVID-19 symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of viral load compared to the baseline on D5;Time to sustained clinical recovery of 5 COVID-19 symptoms(respiratory and feverish symptoms);Time to sustained alleviation of 11 COVID-19 symptoms;Proportion of participants in clinical recovery;AE; | — |
Countries
China
Contacts
Public ContactZhong nanshan;Lu hongzhou
The First Affiliated Hospital of Guangzhou Medical University;The Third People's Hospital of Shenzhen
Outcome results
None listed