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Dexamethasone in Hospitalized Patients with Covid-19

Horby et al., New England Journal of Medicine, doi:10.1056/NEJMoa2021436, RECOVERY, NCT04381936, Feb 2021
https://c19early.org/horby5.html
Mortality 17% Improvement Relative Risk Ventilation 21% Discharge 9% Dexamethasone  RECOVERY  LATE TREATMENT  RCT Is late treatment with dexamethasone beneficial for COVID-19? RCT 6,425 patients in the United Kingdom (March - June 2020) Lower mortality (p=0.00072) and ventilation (p=0.026) c19early.org Horby et al., New England J. Medicine, Feb 2021 Favorsdexamethasone Favorscontrol 0 0.5 1 1.5 2+
RCT 6,425 hospitalized COVID-19 patients showing lower 28-day mortality with dexamethasone treatment. The benefit was most pronounced in patients who had symptoms for more than 7 days at randomization, suggesting dexamethasone is most effective when the disease is dominated by inflammatory processes rather than viral replication.
Standard of Care (SOC) for COVID-19 in the study country, the United Kingdom, is very poor with very low average efficacy for approved treatments1. The United Kingdom focused on expensive high-profit treatments, approving only one low-cost early treatment, which required a prescription and had limited adoption. The high-cost prescription treatment strategy reduces the probability of early treatment due to access and cost barriers, and eliminates complementary and synergistic benefits seen with many low-cost treatments. This may explain in part the very high mortality seen in this study. Results may differ in countries with improved SOC.
risk of death, 17.0% lower, RR 0.83, p < 0.001, treatment 482 of 2,104 (22.9%), control 1,110 of 4,321 (25.7%), NNT 36, adjusted per study.
risk of mechanical ventilation, 21.0% lower, RR 0.79, p = 0.03, treatment 110 of 1,780 (6.2%), control 298 of 3,638 (8.2%), NNT 50, adjusted per study.
risk of no hospital discharge, 9.1% lower, RR 0.91, p = 0.003, treatment 2,104, control 4,321, adjusted per study, inverted to make RR<1 favor treatment.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Horby et al., 25 Feb 2021, Randomized Controlled Trial, United Kingdom, peer-reviewed, mean age 66.1, 26 authors, study period 19 March, 2020 - 8 June, 2020, trial NCT04381936 (history) (RECOVERY).
Dexamethasone in Hospitalized Patients with Covid-19
Peter Horby, Wei Shen Lim, Ph.D Jonathan R Emberson, M.D Marion Mafham, M.Sc Jennifer L Bell, Louise Linsell, D Phil, Ph.D Natalie Staplin, F.Med.Sci Christopher Brightling, Ph.D Andrew Ustianowski, Einas Elmahi, M Phil, Benjamin Prudon, Christopher Green, Ph.D Tim- Othy Felton, Ph.D David Chadwick, Kanchan Rege, F R C Path, M.D Chris- Topher Fegan, Ph.D Lucy C Chappell, F.R.C.P.C.H Saul N Faust, Ph.D Thomas Jaki, Ph.D Katie Jeffery, Ph.D Alan Mont- Gomery, Ph.D Kathryn Rowan, M.Sc Ed- Mund Juszczak, M.D J Kenneth Baillie, Ph.D Richard Haynes, Martin J Landray, Drs Horby
New England Journal of Medicine, doi:10.1056/nejmoa2021436
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.
Appendix The affiliations of the members of the writing committee are as follows: the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 200,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. IMA and WCH provide treatment protocols.
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