Skip to main content
release_alert
Welcome to the new Scholars 3.0! Read about new features and let us know what you think.
cancel
Journal cover image

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.

Publication ,  Journal Article
Tomazini, BM; Maia, IS; Cavalcanti, AB; Berwanger, O; Rosa, RG; Veiga, VC; Avezum, A; Lopes, RD; Bueno, FR; Silva, MVAO; Baldassare, FP ...
Published in: Jama
October 6, 2020

IMPORTANCE: Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients. OBJECTIVE: To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19-associated ARDS. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients. INTERVENTIONS: Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n =151) or standard care alone (n = 148). MAIN OUTCOMES AND MEASURES: The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days. RESULTS: A total of 299 patients (mean [SD] age, 61 [14] years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P = .04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events. CONCLUSIONS AND RELEVANCE: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04327401.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Jama

DOI

EISSN

1538-3598

Publication Date

October 6, 2020

Volume

324

Issue

13

Start / End Page

1307 / 1316

Location

United States

Related Subject Headings

  • SARS-CoV-2
  • Respiratory Distress Syndrome
  • Respiration, Artificial
  • Pneumonia, Viral
  • Pandemics
  • Middle Aged
  • Male
  • Humans
  • General & Internal Medicine
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Tomazini, B. M., Maia, I. S., Cavalcanti, A. B., Berwanger, O., Rosa, R. G., Veiga, V. C., … COALITION COVID-19 Brazil III Investigators, . (2020). 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, 324(13), 1307–1316. https://doi.org/10.1001/jama.2020.17021
Tomazini, Bruno M., Israel S. Maia, Alexandre B. Cavalcanti, Otavio Berwanger, Regis G. Rosa, Viviane C. Veiga, Alvaro Avezum, 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 324, no. 13 (October 6, 2020): 1307–16. https://doi.org/10.1001/jama.2020.17021.
Tomazini, Bruno M., 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, vol. 324, no. 13, Oct. 2020, pp. 1307–16. Pubmed, doi:10.1001/jama.2020.17021.
Tomazini BM, Maia IS, Cavalcanti AB, Berwanger O, Rosa RG, Veiga VC, Avezum A, Lopes RD, Bueno FR, Silva MVAO, Baldassare FP, Costa ELV, Moura RAB, Honorato MO, Costa AN, Damiani LP, Lisboa T, Kawano-Dourado L, Zampieri FG, Olivato GB, Righy C, Amendola CP, Roepke RML, Freitas DHM, Forte DN, Freitas FGR, Fernandes CCF, Melro LMG, Junior GFS, Morais DC, Zung S, Machado FR, Azevedo LCP, 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. 2020 Oct 6;324(13):1307–1316.
Journal cover image

Published In

Jama

DOI

EISSN

1538-3598

Publication Date

October 6, 2020

Volume

324

Issue

13

Start / End Page

1307 / 1316

Location

United States

Related Subject Headings

  • SARS-CoV-2
  • Respiratory Distress Syndrome
  • Respiration, Artificial
  • Pneumonia, Viral
  • Pandemics
  • Middle Aged
  • Male
  • Humans
  • General & Internal Medicine
  • Female