Limitations
EVENTS
The conclusions that may be drawn from ACTIV-4B are limited because the study was terminated early due to a paucity of composite outcome events and limits our ability to perform hierarchical analysis by enrollment location. The trial is unlikely to have enrolled a substantial number of patients with the Delta or omicron variants or full vaccination, and few patients who received monoclonal antibody infusions (e.g., bamlanivimab plus etesevimab), however this data is not available for our population and limits generalizability [