Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Molnupiravir and Standard of Care: Molnupiravir 800 mg (4 capsules of 200 mg) administered orally every 12 hours for 5 days
AND
Standard of Care
Control Intervention1: Standard of Care:
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged �18 and �60 years and voluntarily willing to provide signed and dated informed consent. 2. Patients with laboratory confirmed COVID-19 by SARS CoV2 positive RT-PCR test (within 48 hours prior to enrollment) 3. Patients with mild COVID-19 disease without any evidence of breathlessness. 4. 4. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his/her partner during the study period and for at least 28 days following the last study treatment.
Exclusion criteria
Exclusion criteria: 1. Patients contraindicated or with history/evidence of hypersensitivity to Molnupiravir administration or any of the components of formulation. 2. Patients with moderate disease or severe disease 3. Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN 4. Patients currently taking nucleos(t)ide analogues/ immunosuppressive treatments within 30 days 5. Patients with a history of acute pancreatitis within 3 months 6. Severe renal impairment [creatinine clearance (CrCl) <30 mL/min]
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of TEAEs (clinical and laboratory)Timepoint: All Visits;Mortality rateTimepoint: Day 14 and Day 28;Proportion of patients discontinued the study drug due to adverse eventsTimepoint: All Visits;Proportion of patients with clinical improvementTimepoint: End of Treatment, Day 10 and Day 14;Rate of hospitalizationTimepoint: Up to Day 28;Rate of SARS-CoV2 RT-PCR negativity in nasopharyngeal and/or oropharyngeal swabTimepoint: End of Treatment, Day 10 and Day 14 | — |
Primary
| Measure | Time frame |
|---|---|
| Rate of hospitalizationTimepoint: Up to Day 14 | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Hetero Labs Limited
Outcome results
None listed