Effect of intravenous pulses of methylprednisolone 250 mg versus dexamethasone 6 mg in hospitalized adults with severe COVID‐19 pneumonia: an open‐label randomized trial.

Abstract

Background

The efficacy and safety of high vs. medium doses of glucocorticoids for the treatment of COVID‐19 patients has shown mixed outcomes in controlled trials and observational studies. We aimed to evaluate the effectiveness of methylprednisolone 250 mg bolus vs. dexamethasone 6 mg in patients with severe COVID‐19.

Methods

A randomized, open‐label, controlled trial was conducted between February and August 2021 at four hospitals in Spain. The trial was suspended after the first interim analysis since the investigators considered that continuing the trial would be futile. Patients were randomly assigned in a 1:1 ratio to receive dexamethasone 6 mg once daily for up to 10 days or methylprednisolone 250 mg once daily for 3 days.

Results

Of the 128 randomized patients, 125 were analysed (mean age 60 ± 17 years, 82 males [66%]). Mortality at 28 days was 4.8% in the 250 mg methylprednisolone group vs. 4.8 % in the 6 mg dexamethasone group (absolute risk difference, 0.1% [95% CI, ‐8.8 to 9.1%], P=0.98). None of the secondary outcomes (admission to the intensive care unit, non‐invasive respiratory or high‐flow oxygen support, additional immunosuppressive drugs, or length of stay) or prespecified sensitivity analyses were statistically significant. Hyperglycaemia was more frequent in the methylprednisolone group at 27.0 vs. 8.1 % (absolute risk difference, ‐18.9% [95% CI, ‐31.8 to ‐ 5.6%], P=0.007).

Conclusions

Among severe but not critical patients with COVID‐19, 250 mg/d for 3 days of methylprednisolone compared with 6 mg/d for 10 days of dexamethasone did not result in a decrease in mortality or intubation.