A Study to Assess the Safety and Efficacy of Remdesivir in COVID-19 infected Indian patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/12/039011
- Lead Sponsor
- Jubilant Generics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Age -18 years and above (no upper age limit)
2.Patients admitted in hospital with a proven diagnosis of moderate to severe COVID 19 infection.
3.Patients with moderate disease defined as patients with presence of clinical features pneumonia with dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute.
4.Patients with severe disease defined as patients with clinical signs of pneumonia with respiratory rate >30 breaths/min or severe respiratory distress or SpO2 <90% on room air.
Exclusion Criteria:
1.Known hypersensitivity or idiosyncratic reaction to Remdesivir, its excipients or similar classes of drugs.
2.Inability of subject or legally authorized representative to provide written informed consent.
3.Patients with <40 kg body weight
4.eGFR less than 30 mL per minute
5.Pregnant or nursing women
6.Patients with ALT/AST >= 5 times the upper limit of normal at baseline
7.Evidence of multiorgan failure
8.Mechanically ventilated (including Veno-Venous ECMO) >= 5 days, or any duration of Veno-Arterial ECMO
9.Exposed to other investigational drugs within 30 day of first administration of Remdesivir.
10.Unsuitable for the study in the opinion of the Investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method