CTRI

The study will be conducted over the period of one year on 100 Hospitalized, COVID-19 patients, fulfill the inclusion and exclusion criteria, and are admitted for care at COVID-19 management facilities in Max healthcare Hospital will be eligible for inclusion in the trial. This Phase II, open label, randomized controlled trial. Consecutive patients meeting the inclusion–exclusion criteria and providing informed consent will be randomly assigned to the test and the control group using random numbers generated by randomization.com. Patients in the test group will receive convalescent plasma and the control group will be on standard care.

Baseline data about the demography, clinical presentations, ongoing medical therapy, and clinical history of participants in both arms will be collected and compared. Response to convalescent plasma will be coded as a binary outcome – based on whether the composite primary end point is met or not. Adverse events associated with infusion of convalescent plasma will also be descriptively summarized and compared with the adverse events experienced by participants receiving standard of care.

Eligibility of Potential Donor

1. Only males and nulliparous female donors of weight > 55 kgs will be included.

2. Donor eligibility criteria for whole blood donation as per the departmental SOP will be followed in accordance to the Drugs & Cosmetics Act 1940 and rules 1945 therein (as amended till March 2020). Donor will be screened, followed by brief physical examination.

3. Donors not fit to donate blood based on the history and examination will be deferred and excluded from plasma donor pool for a time period specified by country regulation & departmental SOPs.

4. In addition to the aforementioned donor eligibility criteria, two EDTA samples (5 ml each) and one plain sample (5 ml) will be drawn for the following pre-donation tests as required for convalescent plasmapheresis (CPP).

• Blood group and antibody screening – Antibody screen positive donors will be deferred.

• Complete blood count including Hb, Hct, Platelet count, Total and differential leucocyte count. Donors with Hb>12.5g/dl, platelet count >1, 50,000 per microliter of blood and TLC within normal limits will be accepted.

• Screening for HIV, HBV and HCV by serology and NAT. Donor negative by both the tests will be included.

• Screening for syphilis and malaria by serology. Negative donors will be included

• Total serum protein. Donors with total serum protein > 6gm/dl will be accepted (as per Drugs and Cosmetics (Second Amendment) Rules, 2020)

• Titration of anti-COVID-19 (both IgG and IgM) antibodies and SARS- CoV-2 neutralizing antibodies may be done depending on availability of facilities at the time of testing. (Desired titers for IgG antibodies >1024 or neutralizing antibodies >40) doubling dilution of donor serum will be done and titration will be done using ELISA. If not done at the time of plasma collection the donor samples will be stored in aliquots at <-80° C to be tested at a later date.

• Molecular test for COVID-19 either from nasopharyngeal swab specimens or blood may be done depending on availability of tests. Donors positive will be deferred.