Corona Virus Disease 2019 (COVID-19)
Conditions
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants of 18 years of age or older, at the time of signing of informed consent; 2. Participants who have a positive SARS-CoV-2 test result within 5 days before the randomization allocation; 3. All participants need to meet one or more than one of the following high risks for progression to severe COVID-19, including: (1) Aged >= 60 years ; (2) BMI > 25 kg/m2; (3) With diabetes; (4) With hypertension; (5) With cardiovascular diseases; (6) With chronic lung diseases; (7) With chronic kidney diseases; (8) With cancer; (9) With immunosuppressive disease or immunosuppressive treatment. 4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
Exclusion criteria: 1. Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization; 2. Participants who have SpO2 =30 per minute; 3. Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation; 4. Participants who have eye disease (such as inflammation, vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion); 5. Participants who have one of the following: 1) ALT or AST>1.5 ULN; 2) eGFR <60 mL/min within the last 30 days; 6. Participants who have known allergies to any of the components used in the formulation of the interventions; 7. Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant; 8. Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment); 9. Participants who have received convalescent COVID-19 plasma treatment; 10. Participants use of contraindicated drugs in the Package Insert of nirmatrelvir tablet/ritonavir tablets (co-packaged); 11. Participants who have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed; 12. Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study; 13. Female who is pregnant or breast-feeding or plan to be pregnant within this study period; 14. Male whose wife or partner plan to be pregnant within the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 rebound rate assessed by quantative RT-PCR within 60 days after randomization allocation; | — |
Secondary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 rebound rate assessed by regular RT-PCR within 60 days after randomization allocation;Time to rebound status after treatment;SARS-CoV-2 rebound rate at day 7, 14, 21 and 28 after full-course treatment of study drug;Percentage of the participants who have progression of COVID-19 compared to the next day after treatment completed (within 60 days);Percentage of the participants who have persisting progression of COVID-19 compared to the next day after treatment completed (within 60 days); | — |
Countries
China
Contacts
Public ContactGuang Ning
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Outcome results
None listed