Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19 (HIGHLOWDEXA)

Manuel Taboada Muñiz

Status and phase

Completed

Phase 4

Conditions

Covid19

Corticosteroids

Treatments

Drug: Dexamethasone low dose

Drug: Dexamethasone high dose

Study type

Interventional

Funder types

Other

Identifiers

NCT04726098

HIGHLOWDEXA-COVID

2020-005702-25 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

198 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.