Dexamethasone for COVID-19 Related ARDS: a Multicenter, Randomized Clinical Trial
Status:
Terminated
Trial end date:
2021-05-21
Target enrollment:
Participant gender:
Summary
There is compelling data indicating that there is an excessive inflammatory response in some
patients with COVID-19 leading them to develop ARDS that can be severe with a very poor
prognosis. Many of these patients require very long mechanical ventilation times to survive,
which have led to the collapse of the health system in some regions of the world. The current
evidence for the treatment of these severe forms is inconsistent and most scientific
societies and governmental or international organizations recommend evaluating treatments
with randomized clinical trials. Corticosteroids, being non-specific anti-inflammatory drugs,
could shorten the duration of respiratory failure and improve the prognosis. Due to the lack
of solid data available regarding this serious disease, our objective is to randomly evaluate
the efficacy and safety of the use of dexamethasone, a parenteral corticosteroid approved in
Argentina, in patients with ARDS with confirmed respiratory infection due to SARS-CoV-2
(COVID-19).
After RECOVERY trial prepublication, low dose (6 mg QD for 10 days) dexamethasone was
recommended as the usual care treatment for severe COVID-19. At this time only 3 patients had
been included in the trial. Thus, we updated our recommendations for centers and decided to
compare two different doses of this glucocorticoid for the treatment of ADRS due to COVID-19.
Phase:
Phase 3
Details
Lead Sponsor:
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno