SARS-CoV-2 infection
Conditions
Interventions
Test group:Take 4 tablets of RAY1216 100 mg three times a day for 5 days (15 times)
control group:Take four 100 mg RAY1216 simulants three times a day for 5 days (15 times)
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions; 2. Male and female subjects aged 18-75 years (including 18 and 75 years); 3. COVID-19 nucleic acid was positive, and the CT values of oropharyngeal or nasopharyngeal swabs to detect ORF or N gene of SARS-CoV-2 was lower than 35; 4. Agree to use effective birth control throughout the study period and up to 3 months after discontinuation.
Exclusion criteria
Exclusion criteria: 1. Subjects in severe or critical condition who are currently in need of hospitalization or who are expected to develop into severe or critical condition according to the investigator's judgment; 2. Allergic constitution, or allergic to RAY1216 or its components; 3. Known active liver disease (such as acute or chronic hepatitis B, C, PBC, cirrhosis or acute liver failure, other than non-alcoholic fatty liver disease); 4. Systemic infection other than suspected or confirmed SARS-CoV-2 infection; 5. Subjects who received or expected to receive SARS-CoV-2 vaccine from 14 days before enrollment to D22 follow-up period; 6. Dysphagia or history of gastrointestinal diseases that severely affect drug absorption (including but not limited to reflux disease, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, post-subtotal gastrectomy, etc.); 7. Used anti-novel coronavirus drugs within 7 days before inclusion or planned to use anti-novel coronavirus drugs during the study period (such as Paxlovid, BRII-196/BRII-198, Intravenous infusion of COVID-19 human immunoglobulin or convalescent plasma, etc.); 8. Patients receiving dialysis or with known moderate to severe kidney damage; 9. Subjects with known immunodeficiency, such as malignancies, organ or bone marrow transplantation, HIV infection, or those who have taken immunosuppressive drugs in the last 3 months; 10. Pregnant and lactating women or those who test positive for pregnancy; 11. Patients who have participated in clinical trials of other drugs within 1 month before medication; 12. A concomitant disease requiring hospitalization and/or surgery within 7 days prior to enrollment, or a concomitant life-threatening disease within 28 days prior to enrollment as determined by the investigator; 13. Subjects deemed unfit for study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of SARS-CoV-2 virus nucleic acid turning negative;Proportion of subjects with positive nucleic acid of SARS-CoV-2 virus after 5 days of treatment;Proportion of asymptomatic infected subjects who became mild/normal;Proportion of subjects requiring hospitalization;Recovery time of clinical symptoms; | — |
Countries
China
Contacts
Public ContactNanshan Zhong
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed