Effect of semaglutide on COVID-19 and other infections: an analysis from the FLOW randomized clinical trial

BACKGROUND: In the FLOW trial (Evaluate Renal Function with Semaglutide Once-Weekly; ClinicalTrials.gov, NCT03819153), once-weekly subcutaneous semaglutide 1.0 mg versus placebo reduced the risk of major kidney, cardiovascular (CV) and mortality outcomes in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD). This pre-specified analysis assesses the impact of semaglutide on risks of serious infections and coronavirus disease 2019 (COVID-19) in the FLOW trial. METHODS: The main outcome was a three-component composite [time from randomization to first infection serious adverse event (SAE), first hospitalization due to infection, or all-cause death]. Other outcomes included all infection SAEs, COVID-19 adverse events, COVID-19 SAEs, death due to infection and death concurrent with a COVID-19 SAE. RESULTS: Semaglutide reduced the risk of the main outcome versus placebo [hazard ratio (HR) (95% confidence interval) 0.79 (0.69-0.89); P = .0002]. This risk reduction was greater in subgroups with baseline hemoglobin A1c >8% [HR 0.63 (0.52-0.76)] versus ≤8% [HR 0.93 (0.79-1.11); Pinteraction = .0027], and urine albumin-to-creatinine ratio (UACR) ≥2000 mg/g [HR 0.53 (0.39-0.72)] versus UACR