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Giving steroids to critically ill people with COVID-19 appears beneficial and could save the lives of some, a new meta-analysis and multiple related studies suggest.
Critically ill patients who received systemic corticosteroids were 34% less likely to die within 28 days, for example, compared to others who received usual care or placebo in a prospective meta-analysis of seven randomized controlled trials.
The meta-analysis was published online at JAMA September 2, 2020.
Based on the findings of the meta-analysis, which was sponsored by the World Health Organization (WHO), the organization issued a Living Guide on Corticosteroids for COVID-19 on the same day.
“We recommend systemic corticosteroids for the treatment of patients with severe and critical COVID-19,” the WHO stated in an email to journalists. “We suggest not using corticosteroids in the treatment of patients with non-severe COVID-19 as treatment.”
The studies included in the meta-analysis evaluated the efficacy of corticosteroids among 1703 critically ill patients with confirmed or suspected COVID-19. The median age was 60 years and 29% of the participants were women.
There were 222 deaths among 678 patients randomized to corticosteroids and 425 deaths among 1025 patients randomized to usual care or placebo, for a summary odds ratio of 0.66 (95% confidence interval, 0.53 – 0 , 82; P <0.001) favoring steroid treatment.
A signal strong enough to stop other studies
While the studies were in progress, results from the UK-based Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial were announced on June 16. RECOVERY showed a great benefit of dexamethasone over placebo in this randomized trial of 6425 patients.
“The signal observed in this trial led most of the ongoing corticosteroid trials to discontinue recruitment,” notes lead author of the meta-analysis, Jonathan AC Sterne, MA, MSc, from the University of Bristol in the UK.
Three additional reports, published simultaneously in JAMAalong with the meta-analysis, they were among the studies that were stopped earlier. These trials examined specific agents in patients with severe COVID-19.
In the COVID-19 Dexamethasone Randomized Clinical Trial (CoDEX), researchers found that adding dexamethasone to usual care compared to usual care alone significantly improved the number of days alive and the days patients were free from disease. mechanical ventilation for 28 days. This study of 299 patients from 41 intensive care units in Brazil evaluated people with COVID-19 and moderate to severe acute respiratory distress syndrome (ARDS).
Another research team evaluated hydrocortisone to improve organ support and mortality among 403 people with severe COVID-19 for 21 days. The REMAP-CAP COVID-19 corticosteroid domain randomized clinical trial compared a 7-day fixed-dose cycle of hydrocortisone and dosing, based on appearance of shock, with no hydrocortisone therapy.
The researchers reported a 93% probability that the fixed-dose strategy was superior to no hydrocortisone in improving days without organ support by 21 days. Furthermore, they found an 80% probability that shock-dependent dosing was superior to no therapy of this type with respect to the same outcome.
Although their findings suggest a benefit, the REMAP-CAP investigators cautioned against drawing definitive conclusions because the trial was stopped early and did not meet any statistically significant predetermined endpoints.
In another randomized clinical trial of hydrocortisone, researchers evaluated people with acute respiratory failure and found that hydrocortisone was not associated with a marked reduction in treatment failure rates. Although this rate was 42% lower versus 51% in the placebo group, the difference was not statistically significant.
Practice changing results?
“At the onset of the 2019 coronavirus disease (COVID-19) pandemic, guidance regarding corticosteroids was mixed,” Hallie C. Prescott, MD, University of Michigan, Ann Arbor, and Todd W. Rice , MD, of Vanderbilt University in Nashville, Tennessee, writes in an editorial accompanying the meta-analysis and related studies.
“Overall, the meta-analysis indicates that steroid administration is clearly associated with a benefit among critically ill COVID-19 patients, although the exact threshold at which corticosteroids should be prescribed to an individual patient remains unclear,” they write. .
They also point out that these agents are inexpensive and readily available.
The meta-analysis and three related studies represent “an important step forward in the treatment of patients with COVID-19. While the RECOVERY results were accepted because they offered hope in the treatment of this catastrophic disease, numerous limitations of the study prevented total confidence in the use of corticosteroids in hospitalized patients with COVID-19 “.
“These trials and meta-analysis have built confidence, further defined benefit, and shifted routine care for COVID-19-related ARDS to include corticosteroids,” they added.
Sterne reported receiving grants from the UK National Institute for Health Research (NIHR). Prescott reported that he is part of the Sepsis Survival Campaign Guidelines Panel. Rice reported Cumberland Pharmaceuticals’ personal fees and Avisa Pharma’s personal fees outside of the submitted work.
JAMA. Published online September 2, 2020. Abstract, Editorial
Damian McNamara is a Miami-based Medscape Medical News journalist. It covers a wide range of medical specialties, translating research and the latest medical news into engaging, easy-to-understand stories for busy medical professionals. Reports news from major medical conferences in the United States and abroad.
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