COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45932

Dhruva Chaudhry

dhruvachaudhry@yahoo.co.in

2020-08-24

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

Adult patients with COVID-19 aged 18 years and above <br/ >RT-PCR positive for SARS-CoV-2 <br/ >Willing to give written informed consent <br/ >

Pregnancy or breast feeding <br/ >Hepatic cirrhosis <br/ >Alanine aminotransferase or aspartate aminotransferase more than five times the upper limit of normal <br/ >Known severe renal impairment (estimated glomerular filtration rate <30 mL/min per 1·73 m2) or receipt of continuous renal replacement therapy, haemodialysis, or peritoneal dialysis <br/ >Enrolment into an investigational treatment study for COVID-19 in the 30 days before screening <br/ >Patients of child-bearing age (men and women) not agreeing to take effective contraceptive measures (including hormonal contraception, barrier methods, or abstinence) during the study period and for at least 7 days after the last study drug administration <br/ >Any known hypersensitivity to the study drugs <br/ >Any patient belonging to Severe class of COVID19 disease as per GOI guidelines (MoHFW)

3

Pt B D Sharma post graduate institute of medical sciences

18

100

India

No restriction on type of patients

0: No restriction on type of patients

175

To assess the antiviral efficacy of the investigational products: COVID19 negativity after 7 days of treatmentTimepoint: Baseline; 7 days; 14 days and 28 days

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "", "treatment_id": 1478, "treatment_name": "Daclatasvir+sofosbuvir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1711, "treatment_name": "Ledipasvir+sofosbuvir", "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"}]