SARS-CoV-2 infection
Conditions
Interventions
Experimental group:GST-HG171 tablets combined with ritonavir
Placebo group:Placebo
Positive control group:Paxlovid
Sponsors
The First Affiliated Hospital of Guangzhou Medical University;The Third People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Male or female subjects aged = 18 to = 80 years. 2.The subjects were classified as mild/moderate type COVID-19. 3.Subjects first tested positive for SARS-CoV-2 within 5 days prior to randomization. 4.COVID-19 nucleic acid was positive, and the Ct values was lower than 30. 5.Subjects with mild/moderate COVID-19 had at least one symptom of COVID-19 on the random day.
Exclusion criteria
Exclusion criteria: 1.Need for oxygen, need or expected urgent need for nasal high-flow oxygen therapy or noninvasive positive pressure ventilation, invasive mechanical ventilation or ECMO. 2.SARS-COV-2 infection occurred before Covid-19 was diagnosed. 3.Known history of active liver disease (except Steatosis) , including active hepatitis B or C, primary biliary cirrhosis, Child-Pugh class B or C or acute liver failure. 4.Patients receiving dialysis or with known moderate to severe kidney damage. 5.Human immunodeficiency virus (HIV) infection. 6.Suspected or confirmed active, systemic infection other than Covid-19. 7.A concomitant disease requiring surgery within 7 days prior to enrollment, or a concomitant life-threatening disease within 28 days prior to enrollment as determined by the investigator. 8.Have an allergic reaction to any component of the intervention or have a history of significant allergic disease. 9.Used anti-novel coronavirus drugs within 14 days before inclusion or planned to use anti-novel coronavirus drugs during the study period?(up to day 28). 10.Subjects who received or expected to receive SARS-CoV-2 vaccine from 3 months before enrollment to D28 follow-up period. 11.Women who have a positive pregnancy test during lactation or before drug administration. 12.Subjects deemed unfit for study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral shedding time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in viral load relative to baseline;Proportion of subjects with positive nucleic acid test;Proportion of subjects with recovery of COVID-19 symptoms;Adverse event rates; | — |
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