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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
IV Dexamethasone administered once daily: 16 mg from day 1 to 5 and 8 mg from day 6 to 10
Clínica Bazterrica
Buenos Aires, Argentina
Hospital Universitario Sede Pombo - IUC CEMIC
Buenos Aires, Argentina
Sanatorio Sagrado Corazon
Buenos Aires, Argentina
Hospital Universitario Sede Saaveda - IUC CEMIC
CABA, Argentina
Ventilator-free days at 28 days
Days without ventilator support in the first 28 days following randomization
Time frame: 28 days after randomization
Time to successful discontinuation from mechanical ventilation
Time to event (successful discontinuation from mechanical ventilation)
Time frame: 28 days after randomization
28-days mortality
Dead rate within 28 days of randomization
Time frame: 28 days after randomization
Rate of nosocomial infections
Rate of ventilator associated pneumonia, blood stream infection, urinary tract infection or candidemia in the first 28 days following randomization
Time frame: 28 days after randomization
SOFA variation
Variation in SOFA over the first 10 days after randomization
Time frame: 10 days after randomization
Use of prone position
Cumulative hours spent on prone position
Time frame: 10 days after randomization
Delirium
Frequency of delirium at ICU discharge
Time frame: 28 days after randomization
Muscle weakness
mMRC score at ICU discharge
Time frame: 28 days after randomization
90-day mortality
Death rate within 90 days of randomization
Time frame: 90 days after randomization
Peak daily blood glucose
Interaction between treatment and daily change in glucose
Time frame: 10 days after randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.