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

• Status: Completed
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manuel Taboada Muñiz
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

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.