Evaluation of safety and efficacy of convalescent plasma in COVID-19 patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/04/024804
- Lead Sponsor
- International Stemcell Services Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
18 years and older (male or female)
-Laboratory confirmation of COVID â?? 19
-CT image is characteristic of 2019 novel corona virus pneumonia (optional)
-Sign a consent form and follow the test plan and follow-up process.
Inclusion criteria for donors of plasma
-18 years and older (male or female)
-Patients who have recovered from COVID-19 and who have been discharged from COVID -19 treatment centres or units could be potential donors for CP, from 28 days after their day of discharge.
-COVID patients who have been discharged according to the WHO criteria as: 1) clinically asymptomatic and 2) twice tested negative for SARS-CoV-2 by molecular techniques, should be considered as potential donors. The two samples for SARS-CoV-2 testing should be taken at least 48 hours apart, and the test results should be negative on each sample.
-The donors selected for donation should be RNA negative for COVID and for the transfusion transmissible infections (HIV 1/2, HBV, HCV, malaria and syphilis).
-Sign a consent form and follow the test plan and follow-up process.
-Patients with autoimmune disease in the past or screening
-Those who have serious disease that affect their overall survival as decided by the treating clinican
-Self reports HIV or syphilis infected persons
-Pregnant or lactating women
-Continuous use of immunosuppressive agents or organ transplants in the past 6 months.
Exclusion criteria for donors
-Patients who become sick again after getting discharged
-RNA positive for COVID or TTI positive.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method