Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Molnupiravir 200mg capsules, (4 x 200mg), twice a day: 2 capsules of 200mg each will be given twice a day at interval of 12 hours
Control Intervention1: Standard care of therapy: Oxygen
Sponsors
BDR Pharmaceuticals Internationals PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients between 18 and 60 years of age (both inclusive). 2.Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal and/or oropharyngeal swabs (sample collected �5 days prior to randomization) 3.Patients with moderate COVID-19 and have any one of the following symptoms and signs prior to randomization. Respiratory rate �24/min, breathlessness SpO2: 90% to �93% on room air 4.Patients who are able to consume oral medications. 5.Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: 6.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 8.Female participants of childbearing potential must meet the following criteria to be enrolled:Have a negative pregnancy test prior to randomization. 9.For female subjects: evidence of post-menopause, or for pre-menopause subjects, negative pre-treatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his /her partner during the study period and for at least 28 days following the last study treatment 10.Male participants with female partners must have either Surgical sterilization (vasectomy �1 month before screening) OR 11.Female partner must be of not be of childbearing potential OR Agree to take effective contraceptive measures (barrier methods or abstinence) with his /her partner during the study period and for at least 28 days following the last study treatment. 12.Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures
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 admitted to Intensive Care Unit (ICU) and has any one of the following symptoms. Respiratory rate >30/min, breathlessness SpO2 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, Remdesivir 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 based on previous medical records of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to evaluate the efficacy of Molnupiravir 800mg in the treatment of patients diagnosed with moderate COVID- 19.Timepoint: Proportion of patients with clinical improvement at Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| to evaluate the safety of Molnupiravir 800mg in the treatment of patients diagnosed with moderate COVID- 19.Timepoint: Proportion of patients with clinical improvement at Day 28 Time to clinical improvement from randomization up to 28 days Mortality rate at Day 28 Change in SARS CoV-2 viral load (Cycle Threshold (CT) value of RT- PCRtest) from baseline to EOT, Day 10 and Day 15 Changes in the score of St. Georgeââ?¬â?¢s Respiratory Questionnairefrom base line to EOT visit. | — |
Countries
India
Contacts
Public ContactMukesh Kumar
RAHE LIFE SCIENCE
Outcome results
None listed