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Hydrocortisone (n=76) vs. placebo (n=73)
randomized controlled trial
Low-dose Hydrocortisone
Continuous intravenous infusion of hydrocortisone at an initial dose of 200mg/d. Treatment was continued at 200mg/d until day 7 and then decreased to 100 mg/d for 4 days and 50 mg/d for 3 days, for a total of 14 days. If improvement by day 4, a short treatment regimen was used for a total of 8 days.
Placebo
Saline in a form guaranteeing double-blinding.
Patients received standard care for acute respiratory failure.
COVID-19 severe or critically
Patients aged at least 18 years admitted to 1 of the 9 participating French ICUs for acute respiratory failure with a biologically confirmed (reverse transcriptase–polymerase chain reaction) or suspected (suggestive chest computed tomography scan result in the absence of any other cause of pneumonia) COVID-19. The experimental treatment had to be administered within 24 hours of the onset of the first severity criterion (see below) or within 48 hours for patients referred from another hospital. One of 4 severity criteria had to be present: need for mechanical ventilation with a positive end-expiratory pressure (PEEP) of 5 cm H20 or more; a ratio of PaO2 to fraction of inspired oxygen (FIo2) less than 300 on high-flow oxygen therapy with an FIO2 value of at least 50%; for patients receiving oxygen through a reservoir mask, a PaO2:FIO2 ratio less than 300, estimated using prespecified charts; or a Pulmonary Severity Index greater than 130.
Double-blind.
Multicenter, 9 ICUs in France.
The trial was stopped early following the recommendation of the data and safety monitoring board after the publication of RECOVERY's results.
Hydrocortisone (n=16) vs. placebo (n=14)
randomized controlled trial
Hydrocortisone
IV hydrocortisone 200mg/day for 7 days or until hospital discharge whichever came first. (Continuous infusion over 24 hours or bolus injections every 6 hours (50 mg per bolus)).
Placebo
Matching placebo IV for 7 days or until hospital discharge. (Continuous infusion over 24 hours or bolus injections every 6 hours).
The injections had identical appearances. All other interventions were given at the discretion of the treating clinicians.
COVID-19 severe or critically
Aged 18 years or above AND Confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation ANDUse of one of the following: Invasive mechanical ventilation OR Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system.
Double-blind.
Multicenter
The trial was terminated early when 30 out of 1,000 participants had been enrolled because of external evidence indicating benefit from corticosteroids in severe COVID-19.
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