COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57387

Dr Subhra Lahiri

Subhra.L@axisclinicals.com

2021-07-05

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1.Male and/or female patients aged â?¥ 18 and â?¤ 60 years of age (both inclusive). <br/ >2.Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent. <br/ >3.Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization. <br/ >4.Patients with uncomplicated upper respiratory tract symptoms may have one of the symptoms of fever, cough, sore throat, nasal congestion, malaise, headache or any other signs and COVID-19 symptoms without any evidence of breathlessness or hypoxia (normal saturation) within 5 days prior to the randomization. <br/ >5.Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on). <br/ >6.Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit. <br/ >7.Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization. <br/ >Medically acceptable forms of contraceptive include: <br/ >a.Hormonal contraceptives (at least 1 month before screening visit) <br/ >b.Double barrier methods (e.g., diaphragm with spermicide, or condoms with spermicide) <br/ >c.Intrauterine device (IUD) <br/ >

1.Patients with known hypersensitivity to any of the excipients of the study medication or to any other similar class of drugs. <br/ >2.Patients who participated in any other clinical trial of an experimental treatment for COVID-19 within 90 days prior to randomization. <br/ >3.Patients infected post vaccination of either 1st or 2nd dose. <br/ >4.Patients with one of the following symptoms at the time of screening. <br/ >a. Respiratory rate â?¥ 24/min, breathlessness <br/ >b. SpO2: â?¤ 93% on room air <br/ >5.Patients with pulse rate < 50 beats per minute at rest at the time of screening and randomization <br/ >6.Patients are currently hospitalized or expected to need hospitalization for COVID-19 within 48 hours of randomization. <br/ >7.Patients have 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/ >8.Patients with platelet count <100,000/μL or received a platelet transfusion within 5 days prior to randomization. <br/ >9.Patients with AIDS-defining illness in the past 6 months. <br/ >10.Patients with uncontrolled co-morbid conditions such as hypertension, diabetes, cardiovascular disease, chronic lung/ liver/ kidney disease, cerebro-vascular disease as per the investigatorâ??s discretion. <br/ >11.Patients currently administering or anticipated to require Favipiravir, Oseltamivir or any other anti-viral treatments during study participation. <br/ >12. Patients with Absolute Neutrophil Count (ANC) < 500 mm3. <br/ >13.Patients currently administering immunosuppressive treatments within 30 days of prior to randomization or systemic corticosteroids. <br/ >14.Female patients who are pregnant and/ or breast feeding. <br/ >15.Patients who have any medical condition(s) or has any medical condition(s) which would likely interfere with the conduct or interpretation of the study as per the investigatorâ??s discretion <br/ >

2

Aurobindo Pharma Limited

18

60

India

Mild disease at enrollment

1: Mild disease at enrollment

1220

Rate of hospitalization of patients from randomization up to Day 14. <br/ >Hospitalization is defined as hospital admission for more than 24 hours with respiratory rate â?¥ 24/ minute and SpO2â?¤93% in room air requiring oxygen supplementation.Timepoint: Rate of hospitalization of patients from randomization up to Day 14. <br/ >Hospitalization is defined as hospital admission for more than 24 hours with respiratory rate â?¥ 24/ minute and SpO2â?¤93% in room air requiring oxygen supplementation.

| 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"}]