Adverse Events in IM and IV T-C Groups
deaths, COVID-19 respiratory failure
REGRESSION, INFUSION RELATED REACTION, ADVERSE EVENTS
Abbreviations: IM, intramuscularly; IRR, infusion related reaction; IV, intravenously; NA, not applicable; T-C, study group receiving active treatment with tixagevimab-cilgavimab.Unless otherwise indicated, data are expressed as No. (%) of participants. IM administration consists of 600 mg (300 mg of each component) of monoclonal antibody or 600 mg of placebo; IV administration, 300 mg (150 mg of each component) of monoclonal antibody or 300 mg of placebo.Calculated using Wald test from Poisson regression with robust variance and log-link; risk ratio comparing T-C group vs placebo.Indicates primary outcome.All serious adverse events were hospitalizations. There were no deaths in either study. None of the hospitalizations were considered to be study drug related and were primarily progression of COVID-19 respiratory failure.