OBJECTIVES: To assess the efficacy of inhaled ciclesonide in reducing the risk of adverse outcomes in COVID-19 outpatients at risk of developing severe illness. METHODS: COVERAGE is an open-label, randomised controlled trial. Outpatients with documented COVID-19, risk factors for aggravation, symptoms <7�days and absence of criteria for hospitalisation are randomly allocated to either a control arm or one of several experimental arms, including inhaled ciclesonide. The primary efficacy endpoint is COVID-19 worsening (hospitalisation, oxygen therapy at home, or death) by Day 14. Other endpoints are adverse events, maximal follow-up score on the WHO OSCI, sustained alleviation of symptoms, cure, and RT-PCR and blood parameter evolution at Day 7. The trial's Safety Monitoring Board reviewed the first interim analysis of the ciclesonide arm and recommended halting it for futility. The results of this analysis are reported here. RESULTS: The analysis involved 217 participants (control 107, ciclesonide 110), including 111 women and 106 men. Their median age was 63�years [Interquartile range (IQR) 59-68]. 157/217 (72.4%) had at least one comorbidity. The median time since first symptom was 4�days [IQR 3-5]. During the 28-day follow-up, 2 participants died (control 2/107 [1.9%], ciclesonide 0), 4 received oxygen therapy at home and were not hospitalized (control 2/107 [1.9%], ciclesonide 2/110 [1.8%]) and 24 were hospitalised (control 10/107 [9.3%], ciclesonide 14/110 [12.7%]). In intent-to-treat analysis of observed data, 26 participants reached the composite primary endpoint by Day14, including 12/106 (11. 3%, 95% CI 6.0 to 18.9%) in the control arm and 14/106 (13.2%; 95% CI 7.4 to 21.2%) in the ciclesonide arm. Secondary outcomes were similar for both arms. CONCLUSIONS: Our findings are consistent with the European Medicines Agency's COVID-19 taskforce statement that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19.< Réduire