drugset / Trial / NCT04726098

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

NCT04726098 ↗

Phase 4 Completed 198 enrolled Manuel Taboada Muñiz
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-01-15
Primary completion
2021-08-31
Completion
2021-08-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 6 mg —
Comparator Dexamethasone Small molecule 10 mg —

Indications