the efficacy of high-dose pulse therapy vs. low-dose intravenous methylprednisolone on severe to critical covid-19 clinical outcomes: a randomized clinical trial

Background: it remains unclear which formulation of the corticosteroid regimen has the optimum efficacies on covid-19 pneumonia. objectives: the aim of this study was to compare the clinical outcomes of 2 different regimens in the treatment of acute respiratory distress syndrome (ards) caused by covid-19: methylprednisolone at a dose of 1 mg/kg every 12 hours (low-dose group) and 1000 mg/day pulse therapy for 3 days following 1 mg/kg methylprednisolone every 12 hours (high-dose group). methods: in this randomized clinical trial, patients with mild to moderate ards due to covid-19 were randomly assigned to receive either low-dose (n = 47) or high-dose (n = 48) intravenous methylprednisolone regimens. two groups were matched for age, gender, body mass index (bmi), comorbidities, leukocytes, lymphocytes, neutrophil/lymphocyte, platelet, hemoglobin, and inflammatory markers (erythrocyte sedimentation rate [esr], c-reactive protein [crp], and ferritin). both regimens were initiated upon admission and continued for 10 days. the clinical outcome and secondary complications were evaluated. results: evaluating in-hospital outcomes, no difference was revealed in the duration of intensive care unit (icu) stays (5.4 ± 4.6 vs. 4.5 ± 4.9; p = 0.35), total hospital stays (8 ± 3.1 vs. 6.9 ± 3.4; p = 0.1), requirement rate for invasive ventilation (29.2% vs. 36.2%; p = 0.4) or non-invasive ventilation (16.6% vs 23.4%; p = 0.4), and hemoperfusion (16.6% vs 11.3%; p = 0.3) between the low- and high-dose groups. there was no significant difference in fatality due to ards (29.2% vs. 38.3%; p = 0.3) and septic shock (4.2% vs. 6.4%; p = 0.3) between the low- and high-dose groups. patients in the high-dose group had significantly higher bacterial pneumonia co-infection events compared with those in the low-dose group (18.7% vs 10.6%; p = 0.01). conclusions: the use of adjuvant pulse therapy with intravenous methylprednisolone did not result in improved in-hospital clinical outcomes among patients with mild to moderate ards due to covid-19. a higher risk of bacterial pneumonia should be considered in such cases as receiving a higher dose of steroids.