Open-label, head-to-head, randomized, controlled clinical study of Molnupiravir capsules and Paxlovid tablets in patients with mild and general type of COVID-19 in high-risk populations

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2022
INTERVENTION: Group 1:Molnupiravir;Group 2:Paxlovid; CONDITION: Novel coronavirus pneumonia (COVID‐19) at high risk of severe disease PRIMARY OUTCOME: Days of virus nucleic acid turning from positive to negative; SECONDARY OUTCOME: 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; 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 < 30 when enrolled; 4. Have any of the following risk factors: (1) Aged >=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 mL/ (min·1.73m^2); (4) Patients with chronic pulmonary obstruction; (5) Obesity (BMI > 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, chro
Epistemonikos ID: 86f71db8184938700be255d6cbdb2bec830d2291
First added on: May 15, 2022