A bidimensional early intervention strategy of standard of care in combination with corticosteroids in elderly patients with mild to moderate COVID-19 (BEAT-COV study): a multicentre, open-label, randomized controlled trial.

BACKGROUND: Elderly adults are at high risk for severe coronavirus disease 2019 (COVID-19). Whether the use of corticosteroids in this population with mild to moderate COVID-19 could prevent disease progression remains controversial. METHODS: The BEAT COV trial assessed corticosteroids treatments in elderly patients with mild to moderate COVID-19. Eligible patients were randomly allocated (1:1) to either the intervention group (oral corticosteroids in combination with standard of care (SOC)) or the control group (SOC alone). Non-randomized patients were enrolled in an observational cohort. The primary outcome was the rate of severe or critical COVID-19 within 28 days. RESULTS: The study was terminated prematurely due to low COVID-19 prevalence and decreasing severe cases, leading to an underpowered sample size. A total of 344 patients were screened, 193 patients were randomly allocated to receive corticosteroids in combination with SOC (95 patients) versus SOC alone (98 patients), 151 patients were included in the observational cohort. In the full analysis set (FAS) population, 1 (1.09%) patient in the corticosteroid group and 4 (4.17%) patients in the SOC group developed severe or critical COVID-19 within 28 days (relative risk 0.26 [95% confidence interval {CI} 0.03–2.29]; p = 0.3688). Similar findings were observed in the per-protocol (PP) population. One (0.75%) patient in the observational cohort developed severe COVID-19 within 28 days. All the adverse drug reactions (ADRs) were mild. CONCLUSIONS: In elderly with non-severe COVID-19, the use of corticosteroids combined with SOC did not significantly reduce the incidence of severe or critical COVID-19 compared to SOC alone. And the treatment shows a favorable safety profile. The study is exploratory in nature due to insufficient power, and given the limited evidence, further studies with larger sample sizes are warranted. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05855395, registered on [2023-05-11] (https://clinicaltrials.gov/ct2/show/NCT05855395)