Donors for SARS-CoV-2 Convalescent Plasma for a Controlled Clinical Trial: Donor Characteristics, Content and Time Course of SARS-CoV-2 Neutralizing Antibodies.
2021
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 COVID-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 1:640). 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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