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ORUsing inexpensive and readily available steroids to treat people hospitalized with Covid-19 reduced the risk of death by a third, according to an analysis spanning seven different clinical trials conducted by the World Health Organization and published Wednesday in the Journal of the American Medical Association.
The positive steroid findings, the result of a combined look at data known as a meta-analysis, confirm a similar survival benefit reported in June from a single large study. Corticosteroids are the first and so far only therapy that has been shown to improve the chances of survival of critically ill Covid-19 patients.
Based on recently released data, the WHO on Wednesday issued new treatment guidelines calling for corticosteroids to become the standard of care for “severe and critical” Covid-19 patients. These patients should receive 7 to 10 days of treatment, said a WHO panel. But he cautioned against the use of steroids in patients with non-serious illnesses, saying that “indiscriminate use of any therapy for COVID-19 could rapidly deplete global resources and deprive patients who may benefit most from it as a therapy that could save lives. “
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“The consistent findings of benefit in these studies provide definitive data that corticosteroids should be the first-line treatment for critically ill patients with COVID-19,” said Hallie Prescott and Todd Rice, professors of medicine at the University of Michigan and the Vanderbilt University, respectively. , in an accompanying JAMA editorial.
Nahid Bhadelia, medical director of the Special Pathogens Unit at Boston University School of Medicine, said that “there has been a widespread adoption of steroids in the care of critically ill patients with Covid-19” since the results of the first trial. in June. “This is particularly true in many countries where I work with limited resources. This meta-analysis adds more confidence ”to those results, he added.
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Other groups, including the National Institutes of Health and the Infectious Diseases Society of America, have already issued similar guidelines recommending the use of steroids to treat patients with severe Covid-19.
The new analysis included data on 678 patients randomized to steroid treatment and 1,025 patients to usual care or a placebo. All the patients had a confirmed diagnosis of Covid-19 and were admitted to the hospital. Most were on mechanical ventilation. Twenty-nine percent of the patients were women, but a breakdown by race was not disclosed.
After 28 days, 33% of the steroid-treated patients had died, compared with 41% of the patients who received usual care or a placebo. In the meta-analysis, the difference in absolute mortality translated into a 34% reduction in the risk of death for those who received steroids, a statistically significant result.
Survival benefit remained constant regardless of the type of steroid administered, the dose, or whether the patients were receiving mechanical ventilation or supplemental oxygen only, the researchers found.
Eighteen percent of steroid patients reported side effects compared to 23% of patients with usual care or placebo. Adverse events varied between the trials, but there was no evidence that the risk of serious adverse events was higher in patients allocated to corticosteroids, except in the two smaller trials, in which the total number of serious adverse events was one and three.
Corticosteroids do not directly attack the new coronavirus. Instead, the drugs work by dampening the activity of a patient’s immune system to prevent it from attacking the lungs, a serious and often fatal condition called acute respiratory distress syndrome, or ARDS.
The first evidence that common steroids could improve survival in severe Covid-19 patients came in June when British researchers conducting a large clinical trial called RECOVERY reported that the use of dexamethasone reduced the death rate by 35%. in patients requiring ventilation and in 20% in patients who required oxygen but were not ventilated.
Before the public announcement of the RECOVERY trial results, doctors had been reluctant to use steroids to treat seriously ill Covid-19 patients due to concerns about side effects. Clinical trials with other immunosuppressive drugs such as IL-6 inhibitors also yielded disappointing results.
Patrick Vallance, the UK government’s chief scientific adviser, speaking in June, called the survival benefit of dexamethasone from the RECOVERY study “tremendous news” and “a revolutionary advance in our fight” against Covid-19. But the findings also hampered efforts to confirm the results. Other randomized, controlled clinical trials investigating steroid use at that time were unable to enroll additional patients.
For that reason, the WHO Rapid Evidence Assessment Working Group for COVID-19 Therapies (REACT) stepped in to coordinate the meta-analysis of these incomplete but randomized and controlled trials. The analysis was performed prospectively, meaning that the data and results of the seven individual trials were not known in advance, but were shared for the first time with the WHO team to reduce the possibility of bias.
Three of the individual steroid clinical trials were published in JAMA on Wednesday, along with the WHO meta-analysis.
“The efforts of clinical trial groups to launch and conduct high-quality trials in the midst of a pandemic should be recognized as a major achievement. The agreement between researchers to share unpublished data with the WHO is an example of how science can advance and is critical amid what are likely to be large numbers of underpowered people. [randomized controlled trials]”Prescott and Rice write in their JAMA editorial.
The WHO meta-analysis leaves some questions about steroids and Covid-19 unanswered, said Bhadelia of Boston University.
“It is not yet clear whether it is useful to start [steroids] earlier. Most doctors, including me, would not do it with the current data, “he said, adding that they are also not sure whether to use biomarkers to guide therapy rather than just oxygenation.
One of the concerns about steroids is that, if given too early in the course of Covid-19, they can hamper the body’s ability to clear the virus, leading to worse results. But steroids could also benefit a subset of Covid-19 patients who don’t yet need oxygen but have lab tests that indicate early signs that their immune system is picking up.
“It would be interesting to know if co-administration of an antiviral can help reduce viral load while previous steroids act on the inflammatory component in that group of people,” Bhadelia said. “We also need more data on co-infections in the context of steroid use.”
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