Clinical Data
Comparative Analysis of Phase 3 SIMPLE-Severe Study and Real-World Retrospective Cohort of Patients Diagnosed with Severe COVID-19 Receiving Standard of CareThis comparative pre-planned analysis included 312 patients treated in the Phase 3 SIMPLE-Severe study and a separate real-world retrospective cohort of 818 patients with similar baseline characteristics and disease severity who received standard of care treatment in the same time period as the SIMPLE-Severe study. Patients were primarily located in North America (92 percent, remdesivir cohort vs. 91 percent, standard-of-care cohort), Europe (5 percent vs. 7 percent) and Asia (3 percent vs. 2 percent). The analysis demonstrated that remdesivir treatment was associated with significantly improved clinical recovery and a 62 percent reduction in the risk of mortality compared to standard of care. Findings from the comparative analysis showed that 74.4 percent of remdesivir-treated patients recovered by Day 14 versus 59.0 percent of patients receiving standard of care; recovery was defined as improvement in clinical status based on a 7-point ordinal scale. The mortality rate for patients treated with remdesivir in the analysis was 7.6 percent at Day 14 compared with 12.5 percent among patients not taking remdesivir (adjusted odds ratio 0.38, 95% confidence interval 0.22-0.68, p=0.001).

The results of this comparative analysis add to the previously presented National Institute of Allergy and Infectious Disease (NIAID) randomized, double-blind, placebo-controlled study in hospitalized patients with COVID-19, which showed that remdesivir shortened time to recovery by an average of four days as compared to placebo (11 vs. 15 days; p<0.001). In the NIAID study, patients taking remdesivir trended toward lower mortality compared with those in the placebo group, but this result did not reach statistical significance (7.1 percent vs. 11.9 percent at Day 14; p=0.07).Analyses from the Phase 3 SIMPLE-Severe StudyThe Phase 3 SIMPLE-Severe trial evaluated the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in hospitalized patients with severe manifestations of COVID-19. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive either a 5-day or a 10-day treatment course of remdesivir in addition to standard of care. The results were published in The New England Journal of Medicine in May. An expansion phase of the study was added to enroll up to 5,600 additional patients, including those on mechanical ventilation; results from the expansion phase are pending.Additional new data on the safety and efficacy of remdesivir presented at the Virtual COVID-19 Conference feature subgroup analyses, including race and ethnicity of patients treated in the United States, and global baseline characteristics associated with improved clinical status, and concomitant use of hydroxychloroquine.In this study, 229 patients were enrolled at trial sites in the United States; clinical improvement was defined as a ≥ 2-point improvement on a 7-point ordinal scale. Among these patients, rates of clinical improvement at Day 14 were 84 percent in African American patients (n=43), 76 percent in Hispanic white (HW) patients (n=17), 67 percent in Asian patients (n=18), 67 percent in non-Hispanic white (NHW) patients (n=119) and 63 percent in patients who did not identify with any of these groups (n=32). Key efficacy and safety results with remdesivir treatment across race and ethnicity in the United States are included in the following table.