NCT04726098

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Manuel Taboada Muñiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19
• Corticosteroids

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-15
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2021-01-27
• Last updated: 2021-10-20

Locations

1 site across 1 country: Spain