[HTML][HTML] Donors for SARS-CoV-2 convalescent plasma for a controlled clinical trial: donor characteristics, content and time course of SARS-CoV-2 neutralizing …

S Körper, B Jahrsdörfer, VM Corman, J Pilch… - Transfusion Medicine …, 2021 - karger.com
S Körper, B Jahrsdörfer, VM Corman, J Pilch, P Wuchter, R Blasczyk, R Müller, T Tonn…
Transfusion Medicine and Hemotherapy, 2021karger.com
Background: Convalescent plasma is one of the treatment options for COVID-19 which is
currently being investigated in many clinical trials. Understanding of donor and product
characteristics is important for optimization of convalescent plasma. Methods: Patients who
had recovered from CO-VID-19 were recruited as donors for COVID-19 convalescent
plasma (CCP) for a randomized clinical trial of CCP for treatment of severe COVID-19
(CAPSID Trial). Titers of neutralizing antibodies were measured by a plaque-reduction …
Background
Convalescent plasma is one of the treatment options for COVID-19 which is currently being investigated in many clinical trials. Understanding of donor and product characteristics is important for optimization of convalescent plasma.
Methods
Patients who had recovered from CO-VID-19 were recruited as donors for COVID-19 convalescent plasma (CCP) for a randomized clinical trial of CCP for treatment of severe COVID-19 (CAPSID Trial). Titers of neutralizing antibodies were measured by a plaque-reduction neutralization test (PRNT). Correlation of antibody titers with host factors and evolution of neutralizing antibody titers over time in repeat donors were analysed.
Results
A series of 144 donors (41% females, 59% males; median age 40 years) underwent 319 plasmapheresis procedures providing a median collection volume of 850 mL and a mean number of 2.7 therapeutic units per plasmapheresis. The majority of donors had a mild or moderate course of COVID-19. The titers of neutralizing antibodies varied greatly between CCP donors (from< 1: 20 to> 1: 640). Donor factors (gender, age, ABO type, body weight) did not correlate significantly with the titer of neutralizing antibodies. We observed a significant positive correlation of neutralization titers with the number of reported COVID-19 symptoms and with the time from SARS-CoV-2 diagnosis to plasmapheresis. Neutralizing antibody levels were stable or increased over time in 58% of repeat CCP donors. Mean titers of neutralizing antibodies of first donation and last donation of repeat CCP donors did not differ significantly (1: 86 at first compared to 1: 87 at the last donation). There was a significant correlation of neutralizing antibodies measured by PRNT and anti-SARS-CoV-2 IgG and IgA antibodies which were measured by ELISA. CCP donations with an anti-SARS-CoV-2 IgG antibody content above the 25th percentile were substantially enriched for CCP donations with higher neutralizing antibody levels.
Conclusion
We demonstrate the feasibility of collection of a large number of CCP products under a harmonized protocol for a randomized clinical trial. Titers of neutralizing antibodies were stable or increased over time in a subgroup of repeat donors. A history of higher number of COVID-19 symptoms and higher levels of anti-SARS-CoV-2 IgG and IgA antibodies in immunoassays can preselect donations with higher neutralizing capacity.
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