Hospitalized patients from multiple centers in the United Kingdom with clinically suspected or laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), infection and no medical history that may put the patient at substantial risk while participating in the trial. Pregnant or breast-feeding women were eligible.
Oral or intravenous dexamethasone 6mg daily for up to 10 days or until hospital discharge plus usual care. (N=2,104)
Usual care for Coronavirus Disease 2019 (COVID-19). (N = 4,321)
Primary outcome was all-cause mortality within 28 days. Secondary outcomes were time to discharge from hospital, and for patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation or death.
Effect of Dexamethasone on Primary Outcome of Mortality, According to Respiratory Support at Randomization
The RECOVERY trial was an open-label, randomized, concealed trial analyzed with the intention-to-treat principle, comparing oral/IV dexamethasone 6mg daily for up to 10 days or until hospital discharge with usual care versus usual care alone in treating confirmed or suspected COVID-19. However, usual care did not include remdesivir which has since become standard of care to treat COVID-19. Limitations included a contamination rate of 8% in the control group and a statistically significant older age in the dexamethasone group (that was adjusted for), both of which would bias towards a null effect; and the lack of blinding, Dexamethasone 6mg po/IV daily for ~7 days added to usual care resulted in a 17% relative risk reduction in 28-day mortality when compared with usual care. The largest relative risk reduction of 36% was seen in the treatment group who received invasive mechanical ventilation, and a non-significant trend towards harm in patients not receiving respiratory support or oxygen. Thus, the target population for this treatment would be confirmed or suspected COVID-19 positive, hospitalized patients requiring respiratory support or oxygen. Further studies that evaluate the safety of dexamethasone treatment for COVID-19 are needed due to the lack of assessment of adverse events in this trial.
The RECOVERY-trial studied whether a commonly used corticosteroid, called dexamethasone, was helpful in treating COVID-19 patients. In patients admitted to the hospital and given a diagnosis of or suspected of having COVID-19 infection, dexamethasone, given by mouth or by injection for about 7 days in addition to usual care lowered the chance of dying. Those needing oxygen or use of a machine to help their breathing were helped the most by dexamethasone compared with usual care. This study did not record the adverse side effects of dexamethasone, so it is unclear from this study if patients developed any short term or long term side effects.
Citation: RECOVERY Collaborative Group, Horby P, Lim WS, et al. Dexamethasone in hospitalized patients with COVID-19 - preliminary report. N Engl J Med 2021;384:693–704. doi:10.1056/NEJMoa2021436.
About the Authors
Shogo Kono is a Doctor of Pharmacy Candidate in the Class of 2023 at Western University of Health Sciences in Pomona, CA with strong interests in Critical Care and Emergency Medicine. He has no conflict of interest to report.
Victoria Navarro is a Doctor of Pharmacy Candidate in the Class of 2023 at Western University of Health Sciences in Pomona, CA. She has no conflict of interest to report.
Kellie Gong is a Doctor of Pharmacy Candidate in the Class of 2023 at Western University of Health Sciences in Pomona, CA. She has no conflict of interest to report.
Cynthia Jackevicius, BScPhm, PharmD, MSc, BCPS, BCCP, FCSHP, FAHA, FCCP, FCCS, FACC, a Professor of Pharmacy Practice at Western University of Health Sciences, is the Evidence-Based Practice Section Editor. Dr. Jackevicius teaches evidence-based practice skills to health care professionals. She advocates for the adoption of an evidence-based practice, incorporating the best available evidence, patients’ values and preferences, and clinicians’ expertise into clinical decision-making. She has no conflicts of interest to report.