Clinical Trial to Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Moderate Coronavirus Disease (COVID-19)
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/05/033864
- Lead Sponsor
- MSN Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 121
1.Male or female subjects of 18 years to 60 years age (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 RT-PCR (within 48 hours prior to randomization).
4.Subjects having moderate COVID-19 as per MoH & FW guidelines on ââ?¬Å?Clinical Management Protocol: COVID-19ââ?¬? as updated from time to time.
oModerate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 �93% (range 90-93%) on room air, respiratory rate more or equal to 24 per minute. (Time for symptom onset and baseline should be no more than 10 days).
1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient.
2.Subjects with severe COVID-19: severe pneumonia. with clinical signs of pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90%.
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.Subjects with oxygen saturation (SPO2) below 90% or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) �300 mmHg.
5.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.
6.Pregnant or breast-feeding subjects will be excluded.
7.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).
8.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening.
9.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.
10.Subject has a history of alcohol or drug abuse in the previous 6 months.
11.Subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
12.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis.
13.Anticipated transfer to another hospital which is not a study site within 72 hours.
14.Participated in any other clinical trial or taken investigational drug within 1 month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method