COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56374

Dr Shariq Anwar

sonika.newar@jssresearch.com

2021-06-01

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Subjects will be enrolled in the study if they meet all the following criteria: <br/ > <br/ >2. Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements <br/ > <br/ >3. Male or female patients between 18 and 60 years of age (both inclusive) <br/ > <br/ >4. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected â?¤5 days prior to randomization) <br/ > <br/ >5. Note: If rapid antigen test has been performed and patient found positive then RT-PCR will be performed prior to randomization. <br/ > <br/ >6. Patients with mild COVID-19 and have following symptoms and signs prior to randomization â?¤5 days prior to randomization <br/ > <br/ >7. Upper respiratory tract symptoms (&/or fever) without shortness of breath or hypoxia. <br/ > <br/ >8. As defined by AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group (Directorate General Of Health Services) Ministry of Health & Family Welfare, Government of India- clinical guidance for management of adult COVID-19 patients, dated 22-Apr-2021. <br/ > <br/ >9. Is willing and able to take oral medication <br/ > <br/ >10. Willingness to comply with study instructions for its duration as indicated by written informed consent from the patient <br/ > <br/ >

Subjects will be entered into the study only if they meet none of the following criteria <br/ > <br/ >1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization <br/ > <br/ >2. Pregnancy or lactation <br/ > <br/ >3. History of allergy or hypersensitivity to Molnupiravir or any other treatment component based on investigators assessment <br/ > <br/ >4. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation <br/ > <br/ >5. Tested positive for Human immunodeficiency virus (HIV), <br/ > Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection <br/ > <br/ >6. Abnormal laboratory findings at screening <br/ >Aspartate aminotransferase (AST) >3X upper limit of normal <br/ >Alanine aminotransferase (ALT) >3X upper limit of normal <br/ >Absolute neutrophil count <500/mm3 or per microliter <br/ >Platelet count <100,000 per microliter or /mm3 <br/ >Patients who received a platelet transfusion in the 5 days prior to randomization <br/ > <br/ >7. 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: <br/ > <br/ >8. Participants who are not expected to survive longer than 48 hours at the time of randomization, or <br/ >Participants with a recent history of mechanical ventilation, or <br/ >Participants with conditions that could limit gastrointestinal absorption of capsule contents <br/ > <br/ >9. Receipt of following medication/treatment: <br/ >Ongoing Remdesivir, Favipiravir or any other anti-viral drug, for COVID-19 treatment <br/ >Biological therapy (especially, monoclonal antibody, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit) <br/ > <br/ >10. Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within 5 half-lives (of the drug/ biologic) prior to the randomization (whichever is longer) <br/ >

2

Dr Reddys Laboratories Limited

18

60

India

Mild disease at enrollment

1: Mild disease at enrollment

1218

Rate of hospitalizationTimepoint: 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"}]