A British trial showing that a common steroid could reduce deaths in severe COVID-19 cases by one-third was good news for Minnesota physicians who have been battling the infectious disease without a vaccine or proven treatment — and even better news for intensivists at Hennepin County Medical Center.
They have been using the drug for treatment of severe COVID-19 cases almost from the start of the pandemic, despite discouragement from national medical societies.
“This is helpful because it kind of supports what our practice has been,” said Dr. James Leatherman, director of HCMC’s medical ICU.
The debate over dexamethasone for treatment of severe COVID-19 cases — patients needing ventilation and suffering from acute respiratory distress syndrome (ARDS) — might have been overshadowed by the political fervor over whether to use hydroxychloroquine to treat the disease. But doctors are split over whether the risks of this steroid outweighed the benefits.
Leatherman said most of the 80 patients with COVID-19 and ARDS at his ICU received dexamethasone. Three weeks ago, the hospital also started offering it to COVID-19 patients outside of the ICU to prevent the onset of ARDS that can increase death risks.
“Since we are not randomizing patients, I can’t say what would happen if we didn’t use it, but it’s been our impression that a number of patients seem to improve after we initiate the treatment with these steroids,” said Leatherman, though some severely ill patients still died.
Across town at Abbott Northwestern Hospital in Minneapolis, doctors resolved to wait for clinical trial results before using a steroid that had the potential to boost the novel coronavirus that causes COVID-19. Studies of the drug’s use in the SARS and MERS viral epidemics suggested it had this effect.
Preliminary results of the Recovery trial led by the University of Oxford suggest a strong benefit. The researchers issued a news release Tuesday showing that the drug reduced mortality by one-third in COVID-19 patients placed on ventilators and by one-fifth in patients receiving supplemental oxygen without ventilation.
The drug offered no benefit to patients who didn’t need respiratory support. The study was based on 6,400 patients — with one-third randomly selected to receive the steroid and two-thirds receiving standard care.
“COVID-19 is a global disease — it is fantastic that the first treatment demonstrated to reduce mortality is one that is instantly available and affordable worldwide,” said Martin Landray, a leader of the trial and an Oxford population health professor.
In Minnesota, COVID-19 has been diagnosed through testing in 30,882 patients and caused 1,313 deaths.
Growth in cases has been ebbing, but state health officials are watching for upticks in cases and hospitalizations this week. Protests following the May 25 killing of George Floyd in police custody could have spread the virus.
Any effect from those demonstrations should appear this week, said Kris Ehresmann, state infectious disease director, but increased mobility following the relaxation of state restrictions in June could increase virus transmission as well. That effect might not show up for two weeks.
A state health analysis of the first 2,428 people hospitalized in Minnesota for COVID-19 showed that 666 needed intensive care, 365 needed ventilation, and 335 died in hospitals.
The results of the steroid trial fit the evolving narrative of COVID-19, said Dr. Timothy Schacker, vice dean for research at the University of Minnesota’s School of Medicine. Dexamethasone doesn’t appear to help in the early stage of COVID-19 when the virus is spreading and symptoms are emerging, but he said it could play a lifesaving role in the next phase when the immune system overreacts and exacerbates breathing problems in some patients.
“Most of the damage being done late stage is all about inflammation and an overzealous immune response,” Schacker said. “Dexamethasone suppresses that.”
Schacker said he wouldn’t endorse the drug for Minnesota patients until the full study results are published. The release of preliminary data before it’s published is rare in medicine but more common amid the race to find treatments for COVID-19.
Schacker called dexamethasone a “blunt hammer that just sort of shuts everything down” and said more targeted immune system therapies might end up working as well.
The U has been studying a cancer drug, tocilizumab, that blocks an inflammatory protein called IL-6. Patients with COVID-19 are screened for IL-6 levels to determine if that drug might help prevent immune system overreactions.
Infectious disease experts at Abbott met Tuesday and discussed the findings by respected British researchers but didn’t see enough proof yet to prescribe dexamethasone.
“These are fine investigators, but we have squat for information,” said Dr. Frank Rhame, a virologist at Abbott.
The Infectious Disease Society of America discourages corticosteroids for COVID-19 patients with pneumonia and encourages their use for patients with COVID-19 and ARDS in clinical trials only. The Society of Critical Care Medicine issued only a weak recommendation for steroids in treatment of COVID-19 with ARDS.
Research is finding niches for drugs to treat COVID-19. A U.S. trial validated treatment of COVID-19 with an antiviral drug, remdesivir, which appears most effective in patients who are hospitalized but whose infections haven’t resulted in the need for ventilation.
Studies have found no benefit of hydroxychloroquine. The U will soon publish findings on whether the drug treats early symptoms, but the Food and Drug Administration on Monday revoked its emergency use authorization as a treatment for COVID-19.
Leatherman said other hospitals are using dexamethasone aggressively for COVID-19, and that the decision to offer it earlier to patients, before they developed ARDS and needed ventilation, was based on success at the Henry Ford Hospital in Detroit.
Leatherman is awaiting the final published results of the British study as well, but said the preliminary data suggests even broader use of the drug.
“The problem with COVID has been that it has exploded on us so fast,” he said. “Ideally, we always want to operate on best evidence, which usually means randomized trials. But people have had to make decisions with empirical data. If this [benefit] turns out in fact to be true, it’s very helpful.”