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.
Drug: Dexamethasone high dose
High doses: dexamethasone 20 mg/day 5 days + 10 mg/day 5 days (total 10 days)
Drug: Dexamethasone low dose
Low doses: dexamethasone 6 mg/day 10 days.
Inclusion Criteria:
- Age 18 years or older.
- Hospitalized COVID-19 patients admitted to the Hospital.
- Patients requiring supplemental oxygen. Level 4 using the World Health Organization
7-point Ordinal Scale for clinical improvement
- Patients requiring corticosteroids (dexamethasone) according to Hospital protocol.
Exclusion Criteria:
- Pregnancy or active lactation.
- Patient is expected to die in the next 48 hours.
- Known history of dexamethasone allergy or known contraindication to the use of
corticosteroids.
- Daily use of corticosteroids in the past 15 days.
- Indication for corticosteroids use for other clinical conditions (e.g. refractory
septic shock).
- Consent refusal for participating in the trial.
- Different level of 4 in Level 4 using the World Health Organization 7-point Ordinal
Scale for clinical improvement.
University Clinical Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Manuel Taboada Muñiz, Ph.D., Principal Investigator
University Clinical Hospital of Santiago de Compostela