The World Health Organization (WHO) on Wednesday released updated guidance recommending the use of low-cost steroids to treat hospitalized patients with severe cases of Covid-19, based on a new analysis of seven randomized clinical trials that showed the drugs reduced the risk of death among such patients by one-third.
US new coronavirus cases top 6.1M, deaths surpass 185K
The new guidance comes as U.S. officials as of Thursday morning reported a total of 6,129,400 cases of the novel coronavirus virus since the country's epidemic began—up from 6,088,800 cases reported as of Wednesday morning.
Data from the New York Times shows that Guam and 15 states—Alabama, Connecticut, Iowa, Kansas, Kentucky, Minnesota, Montana, Nebraska, North Carolina, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, and West Virginia—saw their average daily numbers of newly reported coronavirus cases rise over the past 14 days.
The Times' data also shows that the average daily numbers of newly reported coronavirus cases over the past two weeks remained mostly stable in Washington, D.C., and 24 states: Alaska, Arkansas, Colorado, Delaware, Hawaii, Illinois, Indiana, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, New Hampshire, New Jersey, New Mexico, New York, Pennsylvania, Rhode Island, Tennessee, Utah, Vermont, Virginia, and Wisconsin.
In addition, the Times' data shows that Puerto Rico; the U.S. Virgin Islands; and 11 states saw their average daily numbers of newly confirmed coronavirus cases decrease over the past 14 days: Arizona, California, Florida, Georgia, Idaho, Mississippi, Nevada, Oregon, Texas, Washington, and Wyoming.
U.S. officials as of Thursday morning also had reported a total of 185,638 deaths linked to the coronavirus since the country's epidemic began—up from 184,564 deaths reported as of Wednesday morning.
According to the Times' data, 11 states saw their average daily numbers of newly reported deaths linked to the coronavirus rise over the past 14 days: Alabama, Arkansas, Colorado, Georgia, Hawaii, Kentucky, Missouri, Montana, Nebraska, Virginia, and West Virginia.
Analysis shows steroids improve chances of survival among severely ill Covid-19 patients
As the coronavirus continues to spread throughout the world, researchers are scrambling to develop a vaccine against the virus and treatments for Covid-19, the disease caused by the virus. In early June, researchers announced that a common, low-cost steroid called dexamethasone reduced the risk of death among patients with severe cases of Covid-19, giving some hope that widely available steroids could be an effective treatment for such patients.
To evaluate that possibility, WHO's Rapid Evidence Appraisal for Covid-19 Therapies (REACT) Working Group examined data from seven clinical trials involving 1,703 patients with confirmed cases of Covid-19 who were hospitalized. Most of the patients participating in the trials were being treated with ventilators. Among the patients, 678 received corticosteroids, such as dexamethasone, and 1,025 patients received standard Covid-19 care or standard care and a placebo.
Overall, the analysis—published Wednesday in JAMA—showed that 33% of the patients who received corticosteroids died after 28 days, compared with 41% of the patients who received standard care or standard care with a placebo. According to WHO, the difference in absolute mortality between the group of patients who received steroids and the groups who did not represented a 34% reduction in the risk of death among patients who were treated with steroids, which is a statistically significant finding. Further, the analysis showed that patients who received steroids consistently demonstrated the survival benefit regardless of which corticosteroid they received, the dose of the steroids, and whether they had been treated with a ventilator or had received supplemental oxygen without being placed on a ventilator.
According to the analysis, the corticosteroids improved survival among hospitalized patients with severe cases of Covid-19 not by directly combating the novel coronavirus, but by reducing their immune systems' activity and therefore preventing it from attacking their lungs.
The analysis showed that 18% of the patients who received the steroids reported experiencing side effects, compared with 23% of patients who received standard care or standard care with a placebo. According to the analysis, reports of adverse reactions varied across the clinical trials but generally did not appear to indicate that patients who were treated with steroids had a higher risk of serious adverse reactions when compared with other patients.
WHO recommends steroids for severely ill Covid-19 patients
Based on the findings, a WHO panel on Wednesday released new guidelines recommending that providers use systemic corticosteroids to treat hospitalized patients with severe and critical cases of Covid-19. "In contrast to other candidate treatments for Covid-19 that, generally, are expensive, often unlicensed, difficult to obtain, and require advanced medical infrastructure, systemic corticosteroids are low cost, easy to administer, and readily available globally," the panel wrote.
The panel recommended that providers administer the steroids to critically ill Covid-19 patients for a course of seven to 10 days.
Notably, the panel did not recommend using corticosteroids to treat patients with non-severe cases of Covid-19, because the "indiscriminate use of any therapy for Covid-19 would potentially rapidly deplete global resources and deprive patients who may benefit from it most as potentially life-saving therapy," the panel wrote.
In an editorial accompanying the analysis, Hallie Prescott, a professor of medicine at the University of Michigan, and Todd Rice, a professor of medicine Vanderbilt University, wrote, "The consistent findings of benefit in these studies provide definitive data that corticosteroids should be first-line treatment for critically ill patients with Covid-19."
Some experts raise questions of risk
However, some experts have noted that there are still lingering questions concerning the use of steroids to treat Covid-19 patients.
Earlier this year, researchers pointed to study data that indicated using dexamethasone to treat patients with mild cases of Covid-19 could be harmful. And doctors raised concerns that steroids' effects of tampering down patients' immune systems could hinder the body's protective immune response against the coronavirus in patients with mild cases of disease.
Following the release of WHO's new analysis, Nahid Bhadelia, medical director of the Special Pathogens Unit at the Boston University School of Medicine, said, "It still remains unclear if there is any use in starting [steroids during] earlier [stages of Covid-19]. Most clinicians, including myself, would not do so with the current data."
Still, many groups, including NIH and the Infectious Diseases Society of America, and providers are recommending the use of steroids to treat severely ill, hospitalized Covid-19 patients—with caution.
Derek Angus, a critical care doctor at the University of Pittsburgh Medical Center and an author of one of the studies analyzed by WHO, said, "Just because steroids work in sicker patients does not mean to say that we should be cavalierly starting steroids in every patient." He explained that a lot patients "don't need these big-gun drugs that suppress the immune system broadly."
Nevertheless, Rice told the Washington Post that finding a treatment that can reduce the risk of death among severely ill, hospitalized Covid-19 patients is "electrifying."
"[I]t gives us hope, he said, adding, "Maybe we're gaining on this virus" (Harris, "Shots," NPR, 9/2; Feuerstein, STAT News, 9/2; Owens, "Vitals," Axios, 9/3; Guarino, Washington Post, 9/2; Sterne et al., JAMA, 9/2; New York Times, 9/3).