This study summary is an excerpt from the book 2 Minute Medicine’s The Classics in Medicine: Summaries of the Landmark Trials
1. Patients hospitalized with COVID-19 and treated with dexamethasone experienced lower 28-day mortality compared to those treated with usual care.
2. Patients treated with dexamethasone had a shorter hospitalizations compared to those in the usual care group.
Original Date of Publication: February 2021
Study Rundown: Although the majority of coronavirus disease 2019 (COVID-19) cases are asymptomatic or have minor symptoms, many patients need hospital care and can progress to respiratory failure and require ventilatory support. Furthermore, no therapeutic agent had been shown to reduce mortality in patients with more severe COVID-19 infections. This study assessed the use of dexamethasone in patients hospitalized with COVID-19. The study found that patients treated with dexamethasone experienced significantly lower mortality at 28 days when compared to patients in the usual care group. No benefit was found amongst patients who did not require supplemental oxygen therapy. Patients treated with dexamethasone were also noted to have shorter hospitalizations and a greater probability of being discharged within 28 days. The study was limited by the lack of long-term follow-up in patients treated with dexamethasone. Nonetheless, this was the first study to find a therapy that effectively prevented disease progression and lowere mortality in patients with severe COVID-19 infection.
In-Depth [randomized control trial]: This controlled, open-label trial enrolled 6425 patients. Eligible patients included those with confirmed SARS-CoV-2 infection, hospitalized for severe symptoms, and on ventilation or oxygen support. Patients were excluded if dexamethasone was not available at the hospital. Randomization occurred in a 2:1 ratio to receive either usual care alone or usual care plus dexamethasone (oral or IV 6 mg daily), respectively. The primary endpoint was all-cause mortality within 28 days after randomization. Overall, mortality at 28 days was significantly lower in the dexamethasone group (22.9%) compared to patients in the control group (25.7%) (rate ratio 0.83; 95%CI 0.75-0.93; p < 0.001). Subgroup analysis showed there was no benefit in treating patients who did not receive respiratory support in the form of supplemental oxygen with dexamethasone (17.8%) compared to usual care alone (14.0%) (rate ratio 1.19; 95%CI 0.92-1.55). Furthermore, patients treated with dexamethasone had a shorter duration in hospital stay compared to the control group (median 12 vs 13 days). Finally, patients treated with dexamethasone had a greater probability of discharge after 28 days when compared to usual care alone (rate ratio 1.10; 95%CI 1.03-1.17). Overall, dexamethasone was shown to decrease all-cause mortality, shorten the duration of hospitalization, and improve the probability of discharge in hospitalized patients with COVID-19.
The RECOVERY Collaborative Group. Dexamethasone in Hospitalized Patients with COVID-19. N Engl J Med. 2021 Feb 25;384(8):693–704.
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