COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56239

Mr C Devanpally

krreddy@msnlabs.com

2021-05-31

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Male or female subjects of 18 years to 60 years both inclusive <br/ >2. Subject and/or his/her legally accepted representative willing to give written informed <br/ >consent. <br/ >3. Subjects with laboratory confirmation of infection with SARS-CoV-2 by positive RTPCR <br/ >(within 48 hours prior to randomization). <br/ >4 Subjects having mild grade of COVID-19 as per MoH & FW guidelines on â??Clinical <br/ >Management Protocol: COVID-19â?? as updated from time to time. <br/ >a. Mild COVID-19: Patients with uncomplicated upper respiratory tract infection, <br/ >may have mild symptoms such as fever, cough, sore throat, nasal congestion, <br/ >malaise, headache, without evidence of breathlessness or hypoxia (normal <br/ >saturation). (Time for symptom onset and baseline should be no more than 7 <br/ >days).

1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient. <br/ >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 <br/ > <br/ >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). <br/ >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. <br/ > <br/ >5.Pregnant or breast-feeding subjects will be excluded. <br/ >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). <br/ >7.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening. <br/ >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. <br/ >9.Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ >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. <br/ >11.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ >12.Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ >13.Participated in any other clinical trial or taken investigational drug within 1 month. <br/ >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. <br/ >

2

Ms MSN Laboratories Private Limited

18

60

India

Mild disease at enrollment

1: Mild disease at enrollment

1218

To evaluate the efficacy of Molnupiravir Capsule compared to standard of care in confirmed RT-PCR positive patients with mild Coronavirus Disease of 2019 (COVID-19).Timepoint: -Rate of hospitalization from randomization up to Day 14

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

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"}]