Study to assess the efficacy and safety of convalescent plasma in moderate COVID-19 disease.
Phase 2
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/04/024775
- Lead Sponsor
- Indian Council Of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 464
Inclusion Criteria
1.Patients admitted with RT-PCR confirmed COVID-19 illness.
2.Age > 18 years
3.Has any of the two
a.PaO2/ FiO2: 200-300
b.Respiratory Rate > 24/min and SaO2 < 93% on room air
4.Availability of matched donor plasma at the point of enrolment
Exclusion Criteria
1.Pregnant women
2.Breastfeeding women
3.Known hypersensitivity to blood products
4.Receipt of pooled immunoglobulin in last 30 days
5.Critically ill patients:
a.P/F ratio <200 (moderate - severe ARDS)
b.Shock
6.Participating in any other clinical trial
7.Clinical status precluding infusion of blood products
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is a composite measure of the avoidance of - <br/ ><br>1.Progression to severe ARDS (P/F ratio 100) or <br/ ><br>2.All-cause Mortality at 28 days <br/ ><br>Timepoint: 28 days from intervention <br/ ><br>
- Secondary Outcome Measures
Name Time Method