By Jonathan Springston, Editor, Relias Media
A group of British researchers found using a low-cost steroid reduced the mortality rate by one-third among patients hospitalized with severe COVID-19 respiratory complications.
The authors of the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial randomized 2,104 patients to dexamethasone (a cheap and common steroid) 6 mg once per day (either by mouth or by intravenous injection) for 10 days. These patients were compared with 4,321 patients who were randomized to usual care. Dexamethasone reduced deaths by one-third in ventilated patients and by one-fifth in patients receiving oxygen only. There was no observed benefit among patients who did not require respiratory support.
“Dexamethasone is the first drug to be shown to improve survival in COVID-19. This is an extremely welcome result,” Peter Horby, professor of emerging infectious diseases at the University of Oxford and one of the leading investigators for the trial, said in a statement on Tuesday. “The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients. Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.”
Horby and colleagues said they are working to publish the results “as soon as possible.” Because all the data need to go through complete scrutiny and full publication, some are happy for the good news, but eager for more evidence.
“It will be great news if dexamethasone, a cheap steroid, really does cut deaths by 1/3 in ventilated patients with COVID-19, but after all the retractions and walk backs, it is unacceptable to tout study results by press release without releasing the paper,” public health researcher Atul Gawande shared via Twitter.
Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb called the results of the RECOVERY trial “a robust finding” that “could meaningful[ly] affect outcomes.”
“We're learning how to better treat advanced COVID disease and, combined with other new strategies like anticoagulation, we should see COVID mortality rates decline as long as we preserve our healthcare capacity,” Gottlieb shared via Twitter.
The results of the RECOVERY trial were announced one day after the FDA said it is revoking the emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine. Often, President Trump had touted the latter as an effective drug against COVID-19.
“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency said in a statement released Monday. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”
The search for a pharmaceutical solution to COVID-19 continues, and there are dozens of vaccine investigations underway. The upcoming July issue of IRB Advisor includes a pair of articles about the ethics of COVID-19 vaccine investigations. The first article deals with the sensitive nature of a challenge trial, whereby researchers would deliberately infect participants with the disease after attempting to immunize them. Then, researchers would see what happens.
"To put it mildly, that is ethically controversial," Arthur Caplan, PhD, professor of bioethics at NYU Langone Medical Center, said in May during a web conference. "Is it worth taking the risk of compromising subjects to give them, deliberately, a disease?"
Caplan argued that because COVID-19 is a plague that is killing so many people, and years of waiting for a vaccine might result in many more deaths across the world, the benefits outweigh the risks of a challenge study. "The stakes are so high and the impact on the world is so huge that, morally, what is not defensible becomes defensible," Caplan added.
In the second article, experts provide suggestions to IRBs for how to assess potential risks, benefits, and bioethical implications associated with a COVID-19 challenge study.
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