Dexamethasone in Patients With Moderate or Severe ARDS and COVID-19
CoDEX trial design and results
Design
Multicentre, open-label randomised clinical trial
Treatment
Intravenous dexamethasone plus standard care
Control
Standard care alone
Population
299 patients with moderate or severe ARDS due to COVID-19, mean age 61, 37% women
Follow-up
28 days
Primary endpoint
Days alive and free of mechanical ventilation at 28 days
Result
Mean ventilator-free days were 6.6 (95% CI 5.0 to 8.2) with dexamethasone versus 4.0 with standard care alone. The prespecified secondary outcomes — all-cause mortality at 28 days, ICU-free days, duration of mechanical ventilation and the 6-point ordinal scale at 15 days — did not differ significantly.
Secondary endpoints
All-cause mortality, ICU-free days, SOFA score, ventilator-free days at 15 days
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 trial authors, in the published abstract
How it has aged
Published alongside RECOVERY dexamethasone and pointing the same way in the sickest subgroup, which is where RECOVERY's benefit was concentrated. Open-label and far smaller, so it corroborates rather than establishes.
Publications
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
Tomazini BM, Maia IS, Cavalcanti AB, et al. 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 2020 Oct 6;324(13):1307-1316.