Novel coronavirus pneumonia (COVID-19) at high risk of severe disease
Conditions
Interventions
Group 1:Molnupiravir
Group 2:Paxlovid
Sponsors
Beijing Ditan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients (aged >=18 years old) with mild or common novel coronavirus pneumonia who have tested positive for SARS-CoV-2 virus; 2. Within 5 days after the onset of symptoms or positive initial screening; 3. CT value =60 years; (2) Active cancers [excluding small cancers not associated with immunosuppression or significant morbidity/mortality (such as basal cell carcinoma)]; (3) Chronic kidney disease (excluding dialysis patients or EGFR reduction 30); (6) Severe heart disease, such as heart failure, coronary heart disease or cardiomyopathy; (7) Diabetes mellitus; (8) Immunodeficiency or immunosuppression (long-term hormone therapy, organ transplantation, ongoing chemotherapy, immune modulation therapy); (9) Uncontrolled asthma, COPD, bronchitis, chronic kidney disease, chronic respiratory disease, anemia, etc.; 5. Informed consent signed by the patient or the entrusted agent; 6. Patients have no pregnancy plan and voluntarily take effective contraceptive measures within 4 months after randomization; 7. Oral medication may be used or received.
Exclusion criteria
Exclusion criteria: 1. Patients with severe vomiting and difficulty in taking drugs orally or resulting in difficulty in taking drugs after oral administration; 2. Had taken traditional Chinese medicine or proprietary Chinese medicine or other antiviral drugs within 3 days before enrollment; 3. They should not stop taking traditional Chinese medicine or proprietary Chinese medicine or other antiviral drugs after enrollment; 4. Allergic to monapivir or its pharmaceutical components; 5. Allergic to paravide or its pharmaceutical components; 6. Suspected or confirmed active systemic infections other than COVID-19; 7. Patients in which there is no clinical expectation of survival and only hospice care is provided, or cases in deep coma that do not respond to supportive care within three hours of admission; 8. Pregnant or lactating patients; 9. Patients with mental disorders; 10. Patients with severe liver function injury; 11. Patients with contraindications of monapivir or Parovide or who cannot discontinue contraindicated contraindications; 12. The researchers judged that it was not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days of virus nucleic acid turning from positive to negative; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of progression (defined as progression to critical/critical or all-cause death) by day 28;Severe cases;Duration of fever;ICU duration;Time of discharge;Clinical outcome 28 days after initial administration;Time for improvement in lung imaging; | — |
Countries
China
Contacts
Public ContactJin Ronghua
Outcome results
None listed