COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56323

K Ravinder Reddy

antaryami@abiogenesisclinpharm.com

2021-05-28

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1.Male or female subjects of 18 years to 60 years age (both inclusive) <br/ >2.Subject and/or his/her legally accepted representative willing to give written informed consent. <br/ >3.Subjects with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization). <br/ >4.Subjects having moderate COVID-19 as per MoH & FW guidelines on â??Clinical Management Protocol: COVID-19â?? as updated from time to time. <br/ >o Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 â?¤93% (range 90-93%) on room air, respiratory rate more or equal to 24 per minute. (Time for symptom onset and baseline should be no more than 10 days). <br/ >

1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient. <br/ >2.Subjects with severe COVID-19: severe pneumonia. with clinical signs of pneumonia plus one of the following, respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90%. <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.Subjects with oxygen saturation (SPO2) below 90% or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) â?¤300 mmHg. <br/ >5.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/ >6.Pregnant or breast-feeding subjects will be excluded. <br/ >7.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/ >8.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening. <br/ >9.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/ >10.Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ >11.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/ >12.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ >13.Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ >14.Participated in any other clinical trial or taken investigational drug within 1 month. <br/ > <br/ >

2

MSN Laboratories Private Limited

18

60

India

Severe disease at enrollment

6: Severe disease at enrollment

1282

Proportion of patients with clinical improvement at Day fourteen <br/ >Timepoint: Proportion of patients with clinical improvement at Day fourteen <br/ >

| 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"}]