Official Title
Efficacy of Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19
Brief Summary

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.

Detailed Description

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.

Completed
COVID19
Corticosteroids

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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

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

Manuel Taboada Muñiz
NCT Number
Keywords
COVID19
Respiratory failure
Corticosteroids
MeSH Terms
COVID-19
Respiratory Insufficiency
Dexamethasone
Dexamethasone acetate
BB 1101