Outcomes.
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT
The primary outcomes were the nature, incidence, and severity of adverse events, as well as the incidence of clinically significant changes and abnormalities in safety laboratory parameters (hematology, coagulation, biochemistry, and urinalysis), and vital signs (body temperature, blood pressure, heart rate, and respiratory rate). Monitoring for COVID-19 cases and symptoms was included in the safety analyses. The medical assessment of adverse event severity was done in accordance with the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (mild = grade 1, moderate = grade 2, severe = grade 3, potentially life-threatening = grade 4).The following primary PK endpoints (based on PK sample test results of a binding IgG immunoassay and a pseudoviral neutralization assay) were evaluated: AUCNo major changes were made to the planned analyses. Due to pseudoviral neutralization assay sensitivity issues, where the serum concentrations for most samples were below LLOQ for this assay (60 AU/mL), there were limited PK results from the pseudoviral neutralization assay, with only the COVID-HIGIV 400 mg/kg arm having sufficient serum concentration data up to day 4 before dropping below the LLOQ. As such, these data were deemed inappropriate and excluded in this report. The observed concentration at 28 days after dosing (C