COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50222

Dr Jayashri Krishnan

sonika.newar@jssresearch.com

2020-12-24

Recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Treatment

1.Male or female, age â?¥ 18 to â?¤ 65 years <br/ >2.Subject (or legally authorized representative) provides informed consent prior to initiation and comply with planned study procedures. <br/ >3.Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) <br/ >4.Illness of Moderate severity <br/ >

1.Patients with clinical signs of pneumonia plus signs of severe Covid. <br/ >2.Requiring mechanical ventilation or ECMO at screening <br/ >3.Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). <br/ >4.Cardiac failure NYHA Class III, IV and V. <br/ >5.Pregnancy or breast feeding. <br/ >6.Evidence of multiorgan failure <br/ >7.Any malignancy or cerebro-vascular complications <br/ >8.Any other condition as per the physicianâ??s discretion which would make the patient unsuitable for enrollment in the study <br/ >

3

Mylan Laboratories Limited

18

65

India

Moderate disease at enrollment

3: Moderate disease at enrollment

366

1.SARS CoV-2 Viral Negativity Rate <br/ >2.Time to Clinical ImprovementTimepoint: 1.At day 7 <br/ >2.At day 15

| Declared number of arm (4.0) differs from found arms (5.0)

Phase 2

[{"arm_notes": "", "treatment_id": 1478, "treatment_name": "Daclatasvir+sofosbuvir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1957, "treatment_name": "Daclatasvir+nitazoxanide+sofosbuvir", "treatment_type": "Antivirals+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]