Covid-19 Virological confirmation of SARS-CoV-2 infection Covid-19 SARS-CoV-2 molnupiravir favipiravir outpatients
Conditions
Interventions
800 mg (4 capsules) taken orally twice a day (BID) for 5 days,9 tablets two times on Day 1, then 4 tablets twice a day from Day 2 to 5.
Favipiravir treatment is extended (same dosing) to 10 days if cl
- In case of body weight more than 90 kg: 12 tablets two times on Day 1, then 5 tablets twice a day from Day 2 to 5.
Molnupiravir,Favipiravir
Sponsors
National Science and Technology Development Agency (NSTDA)
Department of Medical Services (DMS)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age equal to 18 years or more Initial onset of signs/symptoms attributable to COVID-19 for 5 days or less prior to the day of randomization At least 1 sign/symptom attributable to COVID-19 on the day of randomization Mild or moderate COVID-19 (non severe COVID-19) Positive SARS-CoV-2 RT-PCR or antigenic test (ATK) for 5 days or less (if enrollment based on ATK test result, specimen collection is needed for further confirmation with RT-PCR) At least 1 underlying medical condition associated with an increased risk of severe illness from COVID-19 among the following conditions: - Age equal to 60 years or more - Asthma, mild, moderate to severe - Bronchiectasis (thickening of the lungs airways) - Bronchopulmonary dysplasia (chronic lung disease affecting newborns) - Chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis - Pulmonary embolism - Pulmonary hypertension - Previous pulmonary tuberculosis (after recovery) - Current smoking - Major thalassemia - Hypertension - Coronary heart disease - Chronic kidney disease (CKD) - Chronic liver disease (including cirrhosis CHILD class A (well-compensated disease) or class B (significant functional compromise) if no risk of study treatment toxicity - Hepatocellular carcinoma if no risk of study treatment toxicity - Cancer - Diabetes (type 1 or type 2) - HIV infection - Congenital immunocompromised conditions - Condition or medications that weaken their immune system (i.e., current corticoid treatment) - Body Mass index (BMI) equal to 30 kg/m2 or more - Recent Pregnancy if not breastfeeding - Alcohol or other substance use disorders, if not likely to affect adherence
Exclusion criteria
Exclusion criteria: - Currently hospitalized or expected to need hospitalization for COVID-19 within 48 hours of randomization - Patient with pulmonary involvement as defined in the protocol - Use of monoclonal antibodies planned at time of randomization - Active tuberculosis - Recent stroke or cerebrovascular disease which affects blood flow to the brain - For women: pregnancy, breastfeeding or unwillingness to use contraception during the intervention period and for at least one week after completion of the study treatment - For men: unwillingness to use a reliable method of birth control (contraception) during study treatment with molnupiravir and for at least 3 months after the last dose - Dialysis or estimated glomerular filtration rate <30 ml/min per 1.73 m2 - Hypersensitivity or other contraindication to the drugs - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to, participants who are not expected to survive longer than 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of the study treatment. Examples: patient who recently started chemotherapy, or chronic use of antacid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary involvement By Day 29 after enrollment Clinical and imaging | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization By Day 29 after enrollment Yes or no,Death By Day 29 after enrollment Follow up,Sustained clinical recovery By Day 29 after enrollment Symptom Diary and Telephone interview,Nasopharyngeal SARS-CoV-2 antigenic detection Day 15, Day 29 Antigenic test ,Safety endpoints By Day 29 after enrollment life-threatening adverse events (AE); treatment-related AEs interfering with social with social or functional activities; AE leading to premature treatment discontinuation; serious AE | — |
Countries
Thailand
Contacts
Public ContactPrasert Auewarakul
Siriraj Hospital Faculty of Medicine
Outcome results
None listed