Novel Coronavirus Pneumonia (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; 3. Participants who have one or more mild or moderate COVID-19 symptoms, and total symptom score >= 2: fever, cough, sore throat, stuffy or running nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or difficulty breathing, Chills or shivering; 4. Participants who have one of the following: 1) Sample collection for first positive SARS-CoV-2 viral infection determination = 60 years ; 2) Cardiovascular disease (including congenital hypertension); 3) Chronic lung diseases (for example, chronic obstructive pulmonary disease (COPD), asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, and pulmonary hypertension); 4) Diabetes; 5) Immunosuppressive disease or immunosuppressive treatment(for example long-term use of corticosteroids or other immunosuppressive drugs lead to decreased immune function); 6) Obesity or overweight (BMI > 25 kg/m2); 7) Sickle cell disease; 8) Active cancer; 9) Chronic kidney disease; 10) Current smoker; 11) Neurodevelopmental disorders (e.g., cerebral palsy, Down syndrome) or other conditions that lead to medical complexity (e.g., genetic or metabolic syndrome and severe congenital abnormalities); 12) Requiring relevant medical support (not related to COVID-19) (such as organotomy, gastrostomy, or positive pressure ventilation); 13) Other medical conditions or factors which in the opinion of the Investigator, will place the individual participant at high risk of developing severe COVID-19, and the benefits and risks for participant should be considered.(please refer to Package Insert of nirmatrelvir tablets/ritonavir tablets); 6. Participants who must agree to adhere to contraception restrictions: Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies; 7. Participants who understand and agree to comply with planned study procedures; 8. Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site; 9. 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 during the screening period: 1) ALT or AST>1.5 ULN; 2) eGFR <60 mL/min; 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 this study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to sustained clinical recovery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of the participants who have progression of COVID-19, defined as progress to severe/critical COVID-19 or death from any cause, through Day 28;Percentage of the participants who have progression of COVID-19, defined as progress to severe/critical COVID-19 through Day 28;Percentage of the participants died from any cause through Day 28;Time to clinical symptom absent;Percentage of participants with clinical recovery on Days 3, 5, 7, 10, 14, 21 and 28;Percentage of participants with clinical symptom absent on Days 3, 5, 7, 10, 14, 21 and 28;The change of COVID-19 symptom scores from baseline to Days 3, 5, 7, 10, 14, 21 and 28;The change of WHO Clinical Progress Scale from baseline to Days 3, 5, 7, 10, 14 and 28;Percentage of participants who reduced at least one level of WHO Clinical Progression Scale on Days 3, 5, 7, 10, 14 and 28 compared with baseline;Percentage of participants with SARS-CoV-2 clearance on Days 3, 5, 7, 10 and 14;Changes in SARS-CoV-2 Ct value on Days 3, 5, 7, 10 and 14;Changes in chest CT scan from baseline to Day 7 or 10 (Optional);Safety assessments such as AEs and SAEs through Day 28; | — |
Countries
China
Contacts
Public ContactGuang Ning
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Outcome results
None listed