To Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Mild Corona virus Disease (COVID-19)
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/05/033904
- Lead Sponsor
- Ms MSN Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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).
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 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute
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) <30ml/min).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method