A clinical trial to study the effect of drug named Sofosbuvir in hospitalized patients with COVID 19.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/06/025760
- Lead Sponsor
- Dr N Babu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients more than 18 years of age and proven COVID-19 by RT-PCR for SARS CoV-2 with one of the following criteria
1. requiring hospitalization with acute organ dysfunction(or)
2. SaO2 in room air <93% or need for supplemental oxygen support in any form(or)
3. Infiltrates in Chest X rays or CT Chest or Ultrasound evidence of Pneumonia and
1. Patients with mild symptoms (only fever and cough) and no risk factors
2. Or not requiring any hospitalization,
3. patient with comorbid illnesses with less than 50% survival rate at 1 year (Chronic End Stage Organ Disease).
4. Patient on dialysis or Chronic kidney disease stage 5
5. Patient on drugs: amiodarone, phenytoin, phenobarbital and rifampicin
6.Patient with HBsAg (or) anti Hbc Antibody Positive
7.Patient with anti HCV antibody positive
8.Patient not willing to give consent.
9. Pregnancy/ lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mortality of the study subjectsTimepoint: during hospitalisation
- Secondary Outcome Measures
Name Time Method 1.number of hospitalisation days <br/ ><br>2.number of intensive care unit days <br/ ><br>3.need for invasive ventilation. <br/ ><br>4.number of ventilator days. <br/ ><br>5.period of viral clearanceTimepoint: during hospitalisation