COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56019

Dr Shubhadeep Sinha

sreenivasa.chary@heterodrugs.com

2021-05-21

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Patients aged â?¥18 and â?¤60 years and voluntarily willing to provide signed and dated informed consent. <br/ >2. Patients with laboratory confirmed COVID-19 by SARS CoV2 positive RT-PCR test (within 48 hours prior to enrollment) <br/ >3. Patients with moderate COVID-19 disease i.e., pneumonia with no signs of severe disease <br/ >4. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment 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.

1. Patients contraindicated or with history/evidence of hypersensitivity to Molnupiravir administration or any of the components of formulation. <br/ >2. Patients with severe disease <br/ >3. Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN <br/ >4. Patients currently taking nucleos(t)ide analogues/ immunosuppressive treatments within 30 days <br/ >5. Patients with a history of acute pancreatitis within 3 months <br/ >6. Severe renal impairment [creatinine clearance (CrCl) <30 mL/min] <br/ >7. Having used Molnupiravir or participated in any other interventional clinical study within 30 days

2

Hetero Labs Limited

18

60

India

Moderate disease at enrollment

3: Moderate disease at enrollment

1282

Proportion of patients with clinical improvementTimepoint: 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"}]