COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56466

Mukesh Kumar

mukesh@rahelife.com

2021-06-14

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1.Male or female patients between 18 and 60 years of age (both inclusive). <br/ >2.Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal and/or oropharyngeal swabs (sample collected â?¤5 days prior to randomization) <br/ >3.Patients with moderate COVID-19 and have any one of the following symptoms and signs prior to randomization. <br/ >Respiratory rate â?¥24/min, breathlessness <br/ >SpO2: 90% to â?¤93% on room air <br/ >4.Patients who are able to consume oral medications. <br/ >5.Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ >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 <br/ >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 <br/ >8.Female participants of childbearing potential must meet the following criteria to be enrolled:Have a negative pregnancy test prior to randomization. <br/ >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 <br/ >10.Male participants with female partners must have either Surgical sterilization (vasectomy â?¥1 month before screening) OR <br/ >11.Female partner must be of not be of childbearing potential OR Agree to take effective contraceptive measures (barrier methods or abstinence) with his <br/ >/her partner during the study period and for at least 28 days following the last study treatment. <br/ >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

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. <br/ >Uncontrolled comorbid medical conditions <br/ >Patient is currently admitted to Intensive Care Unit (ICU) and has any one of the following symptoms. <br/ >Respiratory rate >30/min, breathlessness <br/ >SpO2 < 90% on room air <br/ >Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation. <br/ >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. <br/ >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. <br/ >If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. <br/ >Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. <br/ >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. <br/ >A baseline heart rate of < 60 beats per minute at rest <br/ >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 <br/ >Limit gastrointestinal absorption based on previous medical records of the <br/ >patient

2

BDR Pharmaceuticals Internationals PvtLtd

18

60

India

Severe disease at enrollment

6: Severe disease at enrollment

1282

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

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 813, "treatment_name": "Molnupiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]