Study product: COVID-HIGIV.
COVID-HIGIV is prepared from pooled plasma collected at U.S. FDA-licensed and/or registered plasma and/or blood collection centers from healthy, adult donors who have elevated levels of anti-SARS-CoV-2 antibodies. COVID-HIGIV activity against SARS-CoV-2 (product potency) was determined by a validated binding IgG immunoassay (458 AU/mL) that measures the concentration of binding SARS-CoV-2 antibodies (with SARS-CoV-2 trimeric S protein as the antigen) as well as a pseudoviral neutralization assay (3121 AU/mL) that is a validated lentivirus-based SARS-CoV-2 S-protein pseudotype neutralization assay (expressed in Alliance Units [AU]/mL) in relation to a reference standard (purified IgG prepared from pooled plasma with anti-SARS-CoV-2 binding and neutralizing activity). The final drug product is also characterized by a wild-type SARS-CoV-2 neutralization assay (816 AU/mL) performed by NIAID (