COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58743

Dr Subhra Lahiri

Subhra.L@axisclinicals.com

2021-08-04

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 presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization. <br/ >a. Respiratory rate â?¥ 24/min, breathlessness <br/ >b. SpO2: 90% to â?¤ 93% on room air <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/ >

Inclusion Criteria: <br/ >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 presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization. <br/ >a. Respiratory rate â?¥ 24/min, breathlessness <br/ >b. SpO2: 90% to â?¤ 93% on room air <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/ >Exclusion Criteria: <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 pulse rate < 50 beats per minute at rest at the time of screening and randomization. <br/ >5. Patient with severe COVID-19 with any of the following: respiratory failure (including endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (flow rates >20L/min with fraction of delivered oxygen â?¥0.5), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ECMO). <br/ >6. 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/ >7. Patients with platelet count <100,000/μL or received a platelet transfusion within 5 days prior to randomization. <br/ >8. Patients with AIDS-defining illness in the past 6 months. <br/ >9. 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/ >10. Patients currently administering or anticipated to require Favipiravir, Oseltamivir or any other anti-viral treatments during study participation. <br/ >11. Patients with Absolute Neutrophil Count (ANC) < 500 mm3. <br/ >12. Patients currently administering immunosuppressive

2

Aurobindo Pharma Limited

18

60

India

Severe disease at enrollment

6: Severe disease at enrollment

100

Proportion of patients with clinical improvement at Day 14. <br/ >Clinical improvement is defined as 2-point decrease in clinical progression scale as recommended by WHO. <br/ >Timepoint: Day 28

| 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"}]