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A clinical trial to study the effect of drug named Sofosbuvir in hospitalized patients with COVID 19.

Efficacy of Sofosbuvir in the management of hospitalized COVID 19 patients.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025760
Enrollment
50
Registered
2020-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Drug sofosbuvir: sofosbuvir 400 mg twice daily for 10 days in all eligible study subjects along with standard of care including tablet hydroxy chloroquine 400 mg twice a day on day 1 fo

Sponsors

Dr N Babu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 3. Infiltrates in Chest X rays or CT Chest or Ultrasound evidence of Pneumonia and

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
mortality of the study subjectsTimepoint: during hospitalisation

Secondary

MeasureTime frame
1.number of hospitalisation days 2.number of intensive care unit days 3.need for invasive ventilation. 4.number of ventilator days. 5.period of viral clearanceTimepoint: during hospitalisation

Countries

India

Contacts

Public ContactBabu N

Vijaya Medical and Educational Trust

drbabunarayan@gmail.com7299252827

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026