SARS-CoV-2
Conditions
Interventions
1-Experimental group:RAY1216
1-Control group:placebo
2-Experimental group:RAY1216 combined with ritonavir
2-Control group:placebo
Sponsors
Sanya Central Hospital (Hainan Third People's Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and possible adverse events listed in the protocol; 2. Male or female subjects aged 18-70 years at the time of the screening visit; 3. Confirmed SARS-CoV-2 infection as determined by QPCR in any specimen collected within 72 hours prior to randomization (ORF1ab gene or N gene Ct value <= 30); 4. Documentation of first laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid from any respiratory tract specimen collected <= 120 hours prior to enrollment; 5. Agree to use an appropriate method of contraception throughout the study period and up to 3 months after discontinuation.
Exclusion criteria
Exclusion criteria: 1. Subjects who are currently or are expected to develop severe or critical COVID-19 as judged by the investigator; 2. History of hypersensitivity or hypersensitivity to RAY1216, ritonavir or any of the components of the study intervention; 3. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis, including acute or chronic hepatitis B or C infection, primary biliary cirrhosis, liver cirrhosis, or acute liver failure); 4. Suspected or confirmed concurrent active systemic infection other than SARS-CoV-2; 5. Concomitant use of any medications or substances that are strong inducers of CYP3A4 within 28 days before enrollment and during study treatment, or current or expected use of any medications or substances that are highly dependent on CYP3A4 or CYP2D6 for clearance within 24 hours prior to enrollment and for 4 days after the last dose of study drug (see Appendix 1); 6. Has received SARS-CoV-2 vaccine 450 ms; 10. Any of the following abnormalities in blood routine examination at the time of the screening visit: WBC > 1xULN (9.5x10^9/L), or NE = 5xULN, or total bilirubin >= 5xULN), renal insufficiency (serum creatinine > 177 umol/L or 2 mg/dL), cardiovascular and cerebrovascular diseases (including hypertension), nervous system and neuromuscular diseases, metabolic and endocrine system diseases, mental diseases; 12. Known immunodeficiency, such as malignancy, organ or bone marrow transplantation, HIV infection or those taking immunosuppressive drugs in the last 3 months; 13. BMI >= 30 kg/m2; 14. Females who are pregnant or breastfeeding, or with positive serum pregnancy test; 15. Previous administration with any investigational drug or vaccine within 1 month; 16. Other condition, in the investigators judgment, make the participant inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-COV-2 Viral shedding time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in SARS-CoV-2 RNA load from baseline;Proportion of subjects with positive viral RNA load;Time to recovery of COVID-19 symptoms;Adverse event rates; | — |
Countries
China
Contacts
Public ContactLing Lin
Sanya Central Hospital (Hainan Third People's Hospital)
Outcome results
None listed