Safety of the use of methylprednisolone pulses versus dexamethasone in patients with pneumonia due to SARS-CoV-2 infection: Preliminary results

ABSTRACT

Objective: To assess the safety of high-dose bolus methylprednisolone versus intermediate-dose dexamethasone in COVID-19 patients with non-critical respiratory failure (RF). Material and/or methods: Low-intervention, phase IV, open-label, randomized 11, low-intervention clinical trial (CT) • Arm 1 Dexamethasone 6 mg/24 h/10 days. • Arm 2 Methylprednisolone boluses 250 mg/24 h/3 days Safety preliminary results are presented for 127 patients. This CT has been approved by the Spanish Medicines Agency and the Medicines Ethics Committee of the Salamanca Health Area. EudraCT Number 2020-005026-28. Results: 127 hospitalized patients, diagnosed with acutephase SARS-CoV-2 infection and non-critical RF, were recruited between January and August 2021. The mean age was 59.5 years and 66.14% were male. The 93.70% were in stage 5 disease according to WHO criteria and 6.30% in stage 4. There were 55 serious adverse events (SAEs) (32 patients, 78% men) and 7 of them (12.7%) were considered serious adverse reactions (SARs), all of them expected. Six patients died (three in the methylprednisolone group). Of these seven SARs, two (28.5%) belonged to the methylprednisolone group, all in men (mean age 67.5 years) and none resulted in death. The classification by organ and system (SOC) of the registered 55 AEs and SAEs, was as follows 5 vascular disorders cases (methylprednisolone arm 2), 21 respiratory, thoracic and mediastinal disorders cases (methylprednisolone arm 12), 2 gastrointestinal disorders cases (methylprednisolone arm 0), 1 nervous system disorders case (methylprednisolone arm), 26 infections and infestations cases (methylprednisolone arm 13) and 1 cardiac disorders case no related with methylprednisolone. For the seven adverse reactions reported, the classification by SOC was as follows one infections and infestations case and one gastrointestinal disorders case no related with methylprednisolone and five vascular disorders cases (methylprednisolone arm 2). Conclusions: Based on the results obtained, there is no evidence of safety risks associated with high-dose methylprednisolone bolus versus intermediate-dose dexamethasone in patients with COVID-19 with non-critical respiratory failure.