Study Summary

Of the 9433 patients participating in the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial, 7763 were randomized to receive azithromycin plus standard care (n=2582), or standard care alone (n=5181; 837 eventually crossed over to receive azithromycin or tocilizumab but were still included in the analysis). The primary outcome of interest was all-cause mortality at 28 days. Secondary outcomes of interest included time to discharge alive, incidence of discharge within 28 days, and the incidence of invasive mechanical ventilation or death. Additional outcomes of interest included the incidence of ventilation, incidence of non-invasive ventilation, the incidence of invasive mechanical ventilation, the proportion of patients with successful cessation of invasive mechanical ventilation, and the incidence of hemodialysis or filtration use. All outcomes were assessed at 28 days follow up. Results revealed no statistical significant differences between groups in the incidence of all-cause mortality at 28 days (p=0.50). This result was consistent in all subgroups, including age (i.e., ≤70, 70-80, ≥80), sex, ethnicity (i.e., white; black, asian, and minority ethnic), days since symptoms onset (i.e., ≤7; >7), respiratory support at randomization, and use of corticosteroids (p>0.05 for all). The median time to discharge alive was 10 days in the azithromycin group, and 11 days in the control group. There were no statistical significant differences between groups in all secondary and additional outcomes at 28 days follow-up (p>0.05 for all).