The primary and two key secondary end points were tested hierarchically (Table S1). The primary end point was the percentage of patients with at least one Covid-19–related hospitalization or death from any cause through day 29. The key secondary clinical end points were the percentage of patients with at least one Covid-19–related hospitalization or death from any cause from day 4 through day 29 and the time to resolution of Covid-19 symptoms (details are provided in the Supplementary Methods section). For the end point of resolution of symptoms, data on 19 of the 23 symptoms recorded were analyzed.
Data on targeted adverse events were collected in this trial. The safety end points consisted of serious adverse events and adverse events of special interest (i.e., hypersensitivity events of grade 2 or higher, infusion-related reactions, and adverse events for which medical attention at a health care facility was warranted).
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