Dexamethasone for COVID-19 – Preliminary Repor

Dexamethasone for COVID-19 – Preliminary Report

https://www.medrxiv.org/content/10.1101/2020....1.full.pdf

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

Running title: Dexamethasone for COVID-19 – Preliminary Report

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.
Trial registrations: The RECOVERY trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936).

Funding: Medical Research Council and National Institute for Health Research (Grant ref:
MC_PC_19056).
Keywords: COVID-19, dexamethasone, clinical trial.