Trial NCT04395105
Publication Maskin LP, Intensive Care Med (2021) (published paper)
Dates: 2020-06-17 to 2021-03-27
Funding: No specific funding (The author(s) received no financial support for the research, authorship and/or publication of this article.)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Argentina
Follow-up duration (days): 90
Inclusion criteria
  • 18 years old or more
  • ARDS according to the Berlin Definition criteria
  • confirmed SARS-CoV-2 infection by reverse transcription polymerase chain reaction
  • receiving mechanical ventilation for less than 72 hours.
Exclusion criteria
  • Pregnant or breastfeeding
  • terminal disease
  • therapeutic limitation
  • severe immunosuppression
  • chronic treatment with glucocorticoids
  • participation in another randomized clinical trial
  • prior use of dexamethasone for COVID-19 (> 5 days)
  • consent refusal.
Interventions
Treatment
DEX low dose
6 mg intravenously once a day for 10 days
Control
DEX high dose
16 mg intravenously once a day for 5 days, then 8 mg intravenously once a day for 5 days

Participants
Randomized
participants :
DEX low dose=51
DEX high dose=49
Characteristics of participants
N= 100
Mean age : NR
69 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=0 Critical: n=100
Number of vaccinated participants: NR
Primary outcome
In the register
1) Ventilator-free days at 28 days [ Time Frame: 28 days after randomization ]; 2) Time to successful discontinuation from mechanical ventilation [ Time Frame: 28 days after randomization ]
In the report
1) Ventilator-free days during the first 28 days; 2) Time to complete and successful discontinuation of mechanical ventilation or death.
Documents
available

Protocol

Yes. In English

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published report, the pre-print article, the trial registry, protocol and supplementary appendices were used in data extraction and assessment of risk of bias. No statistical analysis plan was available. The primary outcomes in the article reflect those in the registry. The trial (n = 100) was terminated early due to changes in COVID-19 treatment modalities that led to reduced recruitment, so that it did not achieve its target sample size (n = 282).
The study was updated on the March 2nd, 2022 with data extracted from the published report.