Comparison of the efficacy of equivalent doses of dexamethasone, methylprednisolone, and hydrocortisone for treatment of COVID-19-related acute respiratory distress syndrome: a prospective three-arm randomized clinical trial

Abstract

Background This prospective controlled clinical trial aimed to compare the efficacy of methylprednisolone, dexamethasone, and hydrocortisone at equivalent doses in patients with severe COVID-19. Methods In total, 106 patients with mild to moderate COVID-19-related acute respiratory distress syndrome (ARDS) were randomized to receive either dexamethasone (6 mg once a day), methylprednisolone (16 mg twice a day), or hydrocortisone (50 mg thrice a day) for up to 10 days. All participants received a standard of care for COVID-19. The primary and secondary efficacy outcomes included all-cause 28-day mortality, clinical status on day 28 assessed using the World Health Organization (WHO) eight-category ordinal clinical scale, number of patients requiring mechanical ventilation and intensive care unit (ICU) care, number of ventilator-free days, length of hospital and ICU stay, change in PaO 2 :FiO 2 ratios during the first 5 days after treatment, and incidence of serious adverse events. P -values below 0.008 based on Bonferroni’s multiple-testing correction method were considered statistically significant. Results According to the obtained results, there was a trend toward more favorable clinical outcomes in terms of needing mechanical ventilation and ICU care, number of ventilator-free days, change in PaO 2 :FiO 2 ratios during the first 5 days after treatment, clinical status score at day 28, length of ICU and hospital stay, and overall 28-day mortality in patients receiving dexamethasone compared to those receiving methylprednisolone or hydrocortisone; however, likely due to the study’s small sample size, the difference between groups reached a significant level only in the case of clinical status score on day 28 ( p -value = 0.003). There was no significant difference in the incidence of serious adverse events between the study groups. Conclusion Based on the results, severe cases of COVID-19 treated with dexamethasone might have a better clinical status at 28-day follow-up compared to methylprednisolone and hydrocortisone at an equivalent dose. Larger multicenter trials are required to confirm our findings.

Methylprednisolone or dexamethasone? How should we choose to respond to COVID-19?: A systematic review and meta-analysis of randomized controlled trials

“…6). In the 5 studies, [17,18,20–22] there was no significant difference in ICU admissions between the MP group and the DXM group. (RR = 1.17, 95% CI [0.91, 1.50], P = .22, I 2 = 0%) (Fig.…”

“…Six trials in total were included. [17][18][19][20][21][22] The workflow for literature screening is depicted in Figure 1.…”

“…Then, all studies in our analysis were based on quality assessment with low risk of bias. This was a meta-analysis of 6 RCTs [17][18][19][20][21][22] with 1403 COVID-19 patients. All 6 RCTs included in the study showed no significant difference in mortality when comparing methylprednisolone with dexamethasone in the treatment of patients with COVID-19.…”

“…Two of the trials [17,21] used methylprednisolone high-dose pulse therapy, and we performed subgroup analyses that did not yield differential results. Five RCTs [17][18][19]21,22] looked at length of stay. One trial [18] found that dexamethasone had a shorter length of stay than methylprednisolone, while another trial found the opposite.…”

“…Five studies [17][18][19]21,22] compared the length of hospital stay for methylprednisolone versus dexamethasone for COVID-19; a meta-analysis showed no significant difference in the length of stay (mean difference = 0.31, 95% CI [−2.24, 2.85], P = .81, I 2 = 95%) (Fig. 6).…”