Covid-19, Respiratory Distress Syndrome, Adult
Conditions
Brief 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.
Interventions
IV Dexamethasone administered once daily: 16 mg from day 1 to 5 and 8 mg from day 6 to 10
Sponsors
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ARDS according to Berlin's definition * PCR confirmed COVID-19 * Length of mechanical ventilation less or equal to 72 hours
Exclusion criteria
* Pregnancy or breast-feeding women * Terminal illness with very poor prognosis according to the investigator judgement * Therapeutic limitation * Known immunocompromised condition * Chronic use of systemic corticosteroids * Participation in another randomized crinical trial * More than 5 days of treatment of low dose dexamethasone for COVID-19 * Abscence of informed consent * Active participation in other randomized clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free days at 28 days | 28 days after randomization | Days without ventilator support in the first 28 days following randomization |
| Time to successful discontinuation from mechanical ventilation | 28 days after randomization | Time to event (successful discontinuation from mechanical ventilation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle weakness | 28 days after randomization | mMRC score at ICU discharge |
| 28-days mortality | 28 days after randomization | Dead rate within 28 days of randomization |
| Rate of nosocomial infections | 28 days after randomization | Rate of ventilator associated pneumonia, blood stream infection, urinary tract infection or candidemia in the first 28 days following randomization |
| 90-day mortality | 90 days after randomization | Death rate within 90 days of randomization |
| Use of prone position | 10 days after randomization | Cumulative hours spent on prone position |
| Peak daily blood glucose | 10 days after randomization | Interaction between treatment and daily change in glucose |
| SOFA variation | 10 days after randomization | Variation in SOFA over the first 10 days after randomization |
| Delirium | 28 days after randomization | Frequency of delirium at ICU discharge |
Countries
Argentina
Outcome results
None listed