To Study the safety of Remdesivir in COVID-19 Patients.
Not Applicable
- Conditions
- Health Condition 1: - Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 3: J128- Other viral pneumonia
- Registration Number
- CTRI/2020/10/028487
- Lead Sponsor
- AIIMS Patna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
2.Laboratory (RT-PCR) confirmed COVID-19.
3.Lung involvement confirmed with chest imaging
4.Hospitalized with a SaO2/SPO2<=94% on room air or Pa02/Fi02 ratio <300mgHg.
5.Willingness of study participant to take part in this study.
Exclusion Criteria
3.Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the frequency and pattern of subjective ADRs. <br/ ><br>2. To analyse and interpret the objective ADRs through derangements in lab values. <br/ ><br>Timepoint: 3 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. To correlate the appearance of ADRs of Remdesivir with various risk factors. <br/ ><br>2.To collect and correlate any other therapy related event â?? having an impact on patient outcome and drug efficacy. <br/ ><br>Timepoint: 3 months <br/ ><br>