A clinical study to estimate the efficacy and safety of formulation of Molnupiravir in patients with Mild COVID-19 infection.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/06/033992
- Lead Sponsor
- Optimus Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements.
2.Male or female patients between 18 and 60 years of age (both inclusive).
3.Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected <=5 days prior to randomization) Note: If rapid antigen test has been performed and patient found positive then RT-PCR will be performed prior to randomization.
4.Patients with mild COVID-19 and have following symptoms and signs prior to randomization.
Mild: Upper respiratory tract symptoms (&/or fever) without shortness of breath or hypoxia.
5.Patients who are able to consume oral medications.
6.Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
Refrain from donating sperm; and either abstain from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception.
7.Females who are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.
1.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.
2.Uncontrolled comorbid medical conditions.
3.Patient is currently hospitalized or is expected to need hospitalization
for COVID-19 within 48 hours of randomization.
4.Patient is on dialysis or has reduced estimated glomerular filtration rate (73m2eGFR) <30 mL/min/1 by the Modification of Diet in Renal Disease (MDRD) equation.
5.If patient has any of the following conditions: human immunodeficiency virus (HIV); chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm3; autologous or allogeneic hematopoietic stem cell transplant recipient.
6.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.
7.If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization.
8.Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis.
9.Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, Oseltamivir, Remdesivir or any other anti-viral treatments) during study participation as per investigatorâ??s discretion.
10.A baseline heart rate of < 60 beats per minute at rest.
11.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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of Molnupiravir to standard of care in confirmed RT-PCR positive patients with Mild COVID-19Timepoint: Day 1 to Day 5 <br/ ><br> <br/ ><br>RT-PCR will be evaluated on screening, end of treatment day (plus 1) or at the time of early discontinuation. <br/ ><br> <br/ ><br>Note: If RT-PCR test is found to be positive for Day 5 (plus 1) sample, the test may be repeated on Day 10 and on Day 14, if it was positive on Day 10 <br/ ><br> <br/ ><br>Post treatment follow-up Day 10, Day 14(plus 1 Day), 28 Day ( plus 1 Day) <br/ ><br> <br/ ><br>Rate of hospitalization from randomization up to day 14
- Secondary Outcome Measures
Name Time Method Change in SARSCoV-2 viral load (Cycle Threshold (CT) value of RT-PCR test)Timepoint: From Baseline to end of treatment;Incidence and severity of TEAEs (clinical and laboratory)Timepoint: During the study. <br/ ><br>;Mortality rateTimepoint: Day 14;Mortality Rate.Timepoint: At day 28;Proportion of patients discontinued the study drug due to adverse eventsTimepoint: During the study;Proportion of patients with clinical improvementTimepoint: 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: from randomization up to Day 14