Patients hospitalized with coronavirus disease 2019 (COVID-19) and moderate to severe acute respiratory distress syndrome (ARDS) who were treated with dexamethasone experienced more ventilator-free days compared to standard care, according to study results published in the Journal of the American Medical Association.
Researchers conducted a multicenter, randomized, open-label clinical trial (COVID-19-Associated ARDS Treated With Dexamethasone [CoDEX]; ClinicalTrials.gov Identifier: NCT04327401) in 41 intensive care units (ICU) in Brazil. Outcomes from patients with COVID-19 moderate to severe ARDS were examined following treatment and compared between groups. Participants were randomly assigned to receive either standard of care alone or standard of care plus dexamethasone. The primary outcome was ventilator-free days during the first 28 days. Secondary outcomes included all-cause mortality at 28 days as well as other clinical outcomes.
Of the 545 patients assessed for eligibility, 246 were excluded because they did not meet the study exclusion/inclusion criteria. Ultimately, a total of 299 were patients enrolled. The mean age of the study population was 61 years and 37% were women. A total of 151 participants were randomly assigned the dexamethasone group and 148 to the standard care control group.
In the primary study outcome, the dexamethasone group had a mean of 6.6 ventilator-free days compared with 4.0 ventilator-free days in the standard care group (difference, 2.26; P =.04). There were no significant differences in the prespecified secondary outcomes of all-cause mortality or mechanical ventilation at 28 days, ICU-free days during the first 28 days, or the 6-point ordinal scale at 15 days. However, patients who received dexamethasone had significantly lower mean Sequential Organ Failure Assessment scores at 7 days vs those who received standard care (6.1 vs 7.5; difference; -1.16; P =.004).
Study limitations included the open-label trial design, the fact that 35% of patients in the standard care group received corticosteroids, and the trial was underpowered for some of the secondary outcomes.
“Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days,” the researchers wrote.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Tomazini BM, Maia IS, Cavalcanti AB, et al; for COALITION COVID-19 Brazil III Investigators Effect of dexamethasone on days alive and ventilator-free in patients with moderate or severe acute respiratory distress syndrome and COVID-19: the CoDEX Randomized Clinical Trial. JAMA. September 2, 2020. doi:10.1001/jama.2020.17021