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Randomized Controlled Trial

Dexamethasone in Hospitalized Patients with Covid-19

RECOVERY Collaborative Group et al. N Engl J Med. .

Abstract

Background: Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.

Methods: In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the final results of this assessment.

Results: A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.92 to 1.55).

Conclusions: In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.).

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Figures

Figure 1
Figure 1. Enrollment, Randomization, and Inclusion in the Primary Analysis.
At the time of this analysis, completed follow-up forms were available for 2079 of 2104 patients (98.8%) in the dexamethasone group and 4278 of 4321 patients (99.0%) in the usual care group. The subgroup of patients who later underwent a second randomization to tocilizumab versus usual care in the RECOVERY trial included 95 of 2104 patients (4.5%) in the dexamethasone group and 276 of 4321 patients (6.4%) in the usual care group. In addition, 13 patients were randomly assigned to receive either convalescent plasma or usual care alone.
Figure 2
Figure 2. Mortality at 28 Days in All Patients and According to Respiratory Support at Randomization.
Shown are Kaplan–Meier survival curves for 28-day mortality among all the patients in the trial (primary outcome) (Panel A) and in three respiratory-support subgroups according to whether the patients were undergoing invasive mechanical ventilation (Panel B), receiving oxygen only without mechanical ventilation (Panel C), or receiving no supplemental oxygen (Panel D) at the time of randomization. The Kaplan–Meier curves have not been adjusted for age. The rate ratios have been adjusted for the age of the patients in three categories (<70 years, 70 to 79 years, and ≥80 years). Estimates of the rate ratios and 95% confidence intervals in Panels B, C, and D were derived from a single age-adjusted regression model involving an interaction term between treatment assignment and level of respiratory support at randomization.
Figure 3
Figure 3. Effect of Dexamethasone on 28-Day Mortality, According to Respiratory Support at Randomization.
Shown are subgroup-specific rate ratios for all the patients and for those who were receiving no oxygen, receiving oxygen only, or undergoing invasive mechanical ventilation at the time of randomization. Rate ratios are plotted as squares, with the size of each square proportional to the amount of statistical information that was available; the horizontal lines represent 95% confidence intervals.
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