Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Molnupiravir 200 mg: 4 capsules of Molnupiravir 200 mg Twice daily for 5 days will be administered in the IP arm to 609 Covid 19 mild patients.
Control Intervention1: Standard of Care f
Sponsors
Ms MSN Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects of 18 years to 60 years both inclusive 2. Subject and/or his/her legally accepted representative willing to give written informed consent. 3. Subjects with laboratory confirmation of infection with SARS-CoV-2 by positive RTPCR (within 48 hours prior to randomization). 4 Subjects having mild grade of COVID-19 as per MoH & FW guidelines on â??Clinical Management Protocol: COVID-19â?? as updated from time to time. a. Mild COVID-19: Patients with uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache, without evidence of breathlessness or hypoxia (normal saturation). (Time for symptom onset and baseline should be no more than 7 days).
Exclusion criteria
Exclusion criteria: 1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient. 2.Subjects with Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 3.Subjects with history of chronic liver disease (Child Pugh class B or C), severe liver disease like underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 3 times the ULN and chronic renal disease (creatinine clearance (CrCl) 4.Refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug or having undergone extensive bowel resection which may affect adequate absorption of Molnupiravir. 5.Pregnant or breast-feeding subjects will be excluded. 6.Subject currently using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). 7.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening. 8.Subject has history of any serious chronic disease (e.g., human immunodeficiency virus (HIV); cancer requiring chemotherapy within the preceding 6 months; unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. 9.Subject has a history of alcohol or drug abuse in the previous 6 months. 10.Subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 11.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. 12.Anticipated transfer to another hospital which is not a study site within 72 hours. 13.Participated in any other clinical trial or taken investigational drug within 1 month. 14.Any serious medical condition or evidence of multi organ failure or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the subjectâ??s safe participation in and completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Molnupiravir Capsule compared to standard of care in confirmed RT-PCR positive patients with mild Coronavirus Disease of 2019 (COVID-19).Timepoint: -Rate of hospitalization from randomization up to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the safety of Molnupiravir compared to standard of care in confirmed RT-PCR positive patients with mild Coronavirus Disease of 2019 (COVID-19).Timepoint: -Rate of hospitalization from randomization up to Day 28 -Proportion of patients with clinical improvement at the end of treatment, Day 10 and Day 14 -Time to clinical improvement from randomization up to day 14 -Change in SARS CoV2 viral load (Cycle Threshold (CT) value of RT-PCR test) from baseline to end of treatment -Incidence and severity of TEAEs (clinical and laboratory) during the study Proportion of patients discontinued the study drug due to adverse events | — |
Countries
India
Contacts
Public ContactMr C Devanpally
MSN Laboratories Pvt. Ltd
Outcome results
None listed