Convalescent Plasma treatment trial in COVID 19 patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/05/025299
- Lead Sponsor
- Wockhardt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1.Male or female, aged between 18 to 75 years (both inclusive)
2.Hospitalized with RT-PCR confirmed COVID-19 illness and has any one of the below mentioned two:
PaO2/ FiO2 <300
Respiratory Rate > 24/min and SaO2 < 93% on room air
3.Subject or LAR agree to provide a signed written informed consent prior to any study specific procedures and also agree to comply with study requirements
Exclusion Criteria:
1.Receipt of pooled immunoglobulin in past 30 days
2.Contraindication to transfusion or history of prior reactions to transfusion blood products
3.Critically ill patients:
PaO2/ FiO2 ratio <200 (moderate - severe ARDS)
Shock
4.Participating in any other clinical trial
5.Clinical status precluding infusion of blood products
6.Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Avoidance of progression to severe ARDSTimepoint: day 28
- Secondary Outcome Measures
Name Time Method 1.Improvement in symptoms and radiological findings <br/ ><br>2.Change and duration of RT-PCR test turning negative <br/ ><br>3.Change in anti-SARS-CoV-2 titers pre and post plasma transfusion <br/ ><br>4.Evaluate hospital and ICU mortality and length of stay <br/ ><br>5.Evaluate duration and type (invasive or non-invasive) of ventilation support needed <br/ ><br>6.28 days mortality <br/ ><br>Timepoint: 28 days