Low-dose glucocorticoids have been shown to reduce mortality in SARS-CoV-2-infected individuals who require oxygen or ventilatory support (non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation). We evaluated the use of higher doses of glucocorticoids in this group of patients. This randomized, controlled, open-label platform trial [Randomized Evaluation of SARS-CoV-2 Treatments (RECOVERY)] is evaluating multiple possible treatments for patients hospitalized with SARS-CoV-2 infection. Clinical evidence of hypoxia (e.g. oxygen inhalation or oxygen saturation in room air<92%) of eligible and informed consent adult patients were randomly assigned (1:1) to the conventional treatment group with higher doses of glucocorticoids [dexamethasone 20 mg, once a day for 5 days, followed by 10 mg dexamethasone, once a day for 5 days or until discharge (those who did not reach the duration of 5 days)] and to the conventional standard treatment only group [(including dexamethasone 6 mg, once a day for 10 days or those who did not reach the duration of 10 days until discharge)]. The primary study endpoint was 28-day mortality in all randomized subjects. On 11 May 2022, the Independent Data Monitoring Committee recommended that the enrollment of patients without oxygen or with oxygen alone be discontinued for safety reasons. We report the results for these subjects only. Recruitment of patients to receive ventilatory support is still ongoing. The RECOVERY trial is registered with the ISRCTN Trial Records Database (50189673) and the ClinicalTrials.gov Clinical Trials Repository (NCT04381936).
