An Observational study to check safety and effectiveness of CASIRIVIMAB/ IMDEVIMAB treatment of mild/moderate covid 19 patients in India
Phase 4
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/06/034375
- Lead Sponsor
- Roche Products India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. confirmed covid-19 infection
2. Does not require oxygen
3. Symptoms are mil/moderate
4 At high risk for sever Covid 19 infection
Exclusion Criteria
1. hospitalized due to COVID-19
2. Require oxygen therapy due to Covid-19
3. Require an increase in baseline oxygen flow rate due to Covid-19
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The purpose of this study is to assess the real-world safety and efficacy of neutralizing monoclonal antibody (casirivimab/imdevimab) treatment in mild/moderate COVID-19 patients in India, who are at high risk of severe COVID-19 and do not require oxygenTimepoint: The neutralizing antibody will be administered at the baseline visit (Day 0). Visits 1, 2, 3 and 4 will be conducted by phone, at days 7, 14, 28 and 90. Data Collected during Observational Period.
- Secondary Outcome Measures
Name Time Method the rate of Covid-19 related healthcare resource utilization including, but not limited <br/ ><br>to emergency room visits, urgent care/unscheduled visits, and rehabilitationTimepoint: upto Day 90