Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Molnupiravir Tablets 200mg: Molnupiravir Tablets 200mg (4 x 200mg), twice a day for 5 days before food intake
Control Intervention1: Standard of care: Standard of Care
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects will be enrolled in the study if they meet all the following criteria: 2. Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements 3. Male or female patients between 18 and 60 years of age (both inclusive) 4. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected 5. Note: If rapid antigen test has been performed and patient found positive then RT-PCR will be performed prior to randomization. 6. Patients with mild COVID-19 and have following symptoms and signs prior to randomization 7. Upper respiratory tract symptoms (&/or fever) without shortness of breath or hypoxia. 8. As defined by AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group (Directorate General Of Health Services) Ministry of Health & Family Welfare, Government of India- clinical guidance for management of adult COVID-19 patients, dated 22-Apr-2021. 9. Is willing and able to take oral medication 10. Willingness to comply with study instructions for its duration as indicated by written informed consent from the patient
Exclusion criteria
Exclusion criteria: Subjects will be entered into the study only if they meet none of the following criteria 1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization 2. Pregnancy or lactation 3. History of allergy or hypersensitivity to Molnupiravir or any other treatment component based on investigators assessment 4. Patients on dialysis or having reduced glomerular filtration rate (eGFR) 5. Tested positive for Human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection 6. Abnormal laboratory findings at screening Aspartate aminotransferase (AST) >3X upper limit of normal Alanine aminotransferase (ALT) >3X upper limit of normal Absolute neutrophil count Platelet count Patients who received a platelet transfusion in the 5 days prior to randomization 7. Has 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: 8. Participants who are not expected to survive longer than 48 hours at the time of randomization, or Participants with a recent history of mechanical ventilation, or Participants with conditions that could limit gastrointestinal absorption of capsule contents 9. Receipt of following medication/treatment: Ongoing Remdesivir, Favipiravir or any other anti-viral drug, for COVID-19 treatment Biological therapy (especially, monoclonal antibody, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit) 10. Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within 5 half-lives (of the drug/ biologic) prior to the randomization (whichever is longer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of hospitalizationTimepoint: Randomization up to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SARSCoV-2 viral load (Cycle Threshold (CT) value of RT-PCR test)Timepoint: Baseline to end of treatment;Incidence and severity of TEAEs (clinical and laboratory)Timepoint: During study;Mortality rateTimepoint: Day 14;Mortality rate.Timepoint: Day 28;Proportion of patients discontinued the study drug due to adverse eventsTimepoint: During study.;Proportion of patients with clinical improvementTimepoint: At end of treatment, Day 10 and 14;Rate of hospitalizationTimepoint: Randomization up to Day 28;Rate of SARS-CoV2 RT-PCR negativity in nasopharyngeal and/or oropharyngeal swabTimepoint: End of treatment, Day 10 and Day 15;Time to clinical improvementTimepoint: Randomization up to Day 14 | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research Asia Pacific Private Limited
Outcome results
None listed