After RECOVERY trial publication, low dose (6 mg dexamethasone for 10 days) was recommended as the usual care treatment in hospitalized patients with respiratory failure by COVID-19 needing oxygen therapy. RECOVERY trial showed how the use of dexamethasone 6 mg / day for ten days compared to standard treatment without the use of corticosteroids in hospitalized patients reduced mortality at 28 days (22.9% with dexamethasone vs 25.7% without dexamethasone). In the dexamethasone group, the incidence of mortality was lower than standard treatment in patients with hypoxia and the need for mechanical ventilation (29.3% with dexamethasone vs 41.4% without dexamethasone), in patients admitted to the hospital ward with a need for oxygen therapy (23.3% with dexamethasone vs 26.2% without dexamethasone), but they did not find differences between those admitted patients who did not need oxygen therapy. There are two other studies (DEXA-COVID-19 and CoDEX) where they observed benefits of the use of dexamethasone 20 mg / day 5 days, and 10 mg / day 5 days (total 10 days) in patients admitted for respiratory distress syndrome (ARDS) and COVID-19. At present, it is unclear what dose of dexamethasone is most beneficial in patients with COVID-19 and respiratory failure.
Objective: The investigators aim to assess the efficacy of high dose of dexamethasone (20 mg / day 5 days, and 10 mg/day 5 days) versus low dose of dexamethasone (6 mg/day 10 days) in patients with respiratory failure by COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
198
High doses: dexamethasone 20 mg/day 5 days + 10 mg/day 5 days (total 10 days)
Low doses: dexamethasone 6 mg/day 10 days.
University Clinical Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Percentage of patients with treatment failure at day 11
defined as death, need of ICU and extracorporeal membrane oxygenation, need of non-invasive ventilation or nasal high-flow oxygen therapy, or worsening of the condition clinic of the patient during treatment (two of these: need to increase Fraction of inspired oxygen inspired\>20%, need for fraction inspired oxygenation\>50%, increase in respiratory rate\>25, increase in inflammatory markers).
Time frame: Day 11 after randomization
Percentage of patients without the need for oxygen support at day 11.
Time frame: Day 11 after randomization
28-days mortality
Time frame: 28 days after randomization
90-days mortality
Time frame: 90 days after randomization
Clinical status of patients using the World Health Organization 7-point Ordinal Scale for clinical improvement during 10 days of treatment
1:Not hospitalized, 2:Hospitalized and not treatment, 3: Hospitalized with treatment, not requiring supplemental oxygen, 4:Hospitalized requiring supplemental oxygen, 5:Hospitalized, requiring non-invasive ventilation or nasal high-flow oxygen therapy, 6: Hospitalized requiring invasive ventilation or Extracorporeal (ECMO)
Time frame: 10 days after randomization
Percentage of patients needing Intensive Care Unit admission
Time frame: 28 days after randomization
Percentage of patients needing invasive mechanical ventilation or extracorporeal membrane oxygenation
Time frame: 28 days after randomization
Percentage of patients needing non-invasive ventilation or nasal high-flow oxygen therapy
Time frame: 28 days after randomization
Length of stay in the hospital
Time frame: 90 days after randomization
Infectious complications during hospital admission
Time frame: 90 days after randomization
Adverse drug reactions
Time frame: 11 days after randomization
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