Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Molnupiravir 800 mg capsules: Molnupiravir 800 mg (4 capsules of 200 mg or 2 capsules of 400 mg) (BID) + Standard of care.
Patients will be instructed to take Molnupiravir 800 mg (4 x 2
Sponsors
Strides Pharma Science Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements. Male or female patients between 18 and 60 years of age (both inclusive). Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected �5 days prior to randomization) Patients with mild COVID-19 (non-hospitalized) and have following symptoms and signs within 3 to 5 days prior to randomization. Patients having mild COVID-19 with a score of 2 or 3 on the 10-point ordinal scale of clinical status Patients who are able to consume oral medications. Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Females who are not pregnant or breastfeeding
Exclusion criteria
Exclusion criteria: Known hypersensitivity or contraindications to any of the components of the study interventions or to any other similar class of drugs as determined by the investigator. Uncontrolled comorbid medical conditions. Patient is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) If patient has any of the following conditions: human immunodeficiency virus (HIV); chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count If patient has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening. If patient has a platelet count Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, oseltamivir or any other anti-viral treatments) during study participation as per investigatorââ?¬•s discretion. A baseline heart rate of If patient 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: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of hospitalization from randomization up to day 14.Timepoint: Rate of hospitalization from randomization up to day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of hospitalization from randomization up to day 28. Proportion of patients with clinical improvement at the end of treatment day 10 and 14. Time to clinical improvement from randomization up to day 14. Mortality rate at day 14. Mortality rate at day 28. Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Vimla Dsouza
Arcolab Pvt Ltd
Outcome results
None listed