Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report

Horby, Peter; Lim, Wei Shen; Emberson, Jonathan; Mafham, Marion; Bell, Jennifer; Linsell, Louise; Staplin, Natalie; Brightling, Christopher; Ustianowski, Andrew; Elmahi, Einas; Prudon, Benjamin; Green, Christopher; Felton, Timothy; Chadwick, David; Rege, Kanchan; Fegan, Christopher; Chappell, Lucy C; Faust, Saul N; Jaki, Thomas; Jeffery, Katie; Montgomery, Alan; Rowan, Kathryn; Juszczak, Edmund; Baillie, J Kenneth; Haynes, Richard; Landray, Martin J; RECOVERY Collaborative Group

Abstract

Background Coronavirus disease 2019 (COVID-19) is associated with diffuse lung damage. Corticosteroids may modulate immune-mediated lung injury and reducing progression to respiratory failure and death.

Methods The Randomised Evaluation of COVID-19 therapy (RECOVERY) trial is a randomized, controlled, open-label, adaptive, platform trial comparing a range of possible treatments with usual care in patients hospitalized with COVID-19. We report the preliminary results for the comparison of dexamethasone 6 mg given once daily for up to ten days vs. usual care alone. The primary outcome was 28-day mortality.

Results 2104 patients randomly allocated to receive dexamethasone were compared with 4321 patients concurrently allocated to usual care. Overall, 454 (21.6%) patients allocated dexamethasone and 1065 (24.6%) patients allocated usual care died within 28 days (age-adjusted rate ratio [RR] 0.83; 95% confidence interval [CI] 0.74 to 0.92; P<0.001). The proportional and absolute mortality rate reductions varied significantly depending on level of respiratory support at randomization (test for trend p<0.001): Dexamethasone reduced deaths by one-third in patients receiving invasive mechanical ventilation (29.0% vs. 40.7%, RR 0.65 [95% CI 0.51 to 0.82]; p<0.001), by one-fifth in patients receiving oxygen without invasive mechanical ventilation (21.5% vs. 25.0%, RR 0.80 [95% CI 0.70 to 0.92]; p=0.002), but did not reduce mortality in patients not receiving respiratory support at randomization (17.0% vs. 13.2%, RR 1.22 [95% CI 0.93 to 1.61]; p=0.14).

Conclusions In patients hospitalized with COVID-19, dexamethasone reduced 28-day mortality among those receiving invasive mechanical ventilation or oxygen at randomization, but not among patients not receiving respiratory support.

Citation

Horby, P., Lim, W. S., Emberson, J., Mafham, M., Bell, J., Linsell, L., …RECOVERY Collaborative Group. Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report

• Working Paper Type: Working Paper
• Deposit Date: Feb 8, 2023
• Publicly Available Date: Feb 9, 2023
• Public URL: https://nottingham-repository.worktribe.com/output/4737035
• Publisher URL: https://www.medrxiv.org/content/10.1101/2020.06.22.20137273v1
• Additional Information: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.