Albert Einstein College of Medicine and Montefiore Health System recently concluded that its study results align with those of Oxford’s RECOVERY clinical trial centering on the use of steroids for COVID-19 patients. Thanks to these prestigious New York City healthcare and research institutions, material medical evidence is advanced, as several key questions are addressed, such as “Which patients are most likely to benefit from steroid therapy? Could some of them (patients) be harmed? Can other formulations of steroids substitute for the agent studied in the British Trial?” TrialSite provides a brief review. To summarize, multiple formulations of steroids can benefit COVID-19 patients while a common blood test can help determine ideal patient selection for steroid therapy.
With the findings recently published in the Journal of Hospital Medicine, the recent Albert Einstein College of Medicine and Montefiore Health System address questions raised by the conclusion of the UK RECOVERY trial covered by the TrialSite. The study’s title is “Effect of Systemic Glucocorticoids on Mortality or Mechanical Ventilation in Patients with COVID-19.”
The RECOVERY Trial Findings
The UK Recovery file, sponsored by the University of Oxford, concluded that dexamethasone lowers the death rate for severe to critically ill COVID-19 patients receiving mechanical ventilation versus the standard of care. National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci recently announced that dexamethasone, the low-cost, available steroid, would be included in the National Institutes of Health (NIH) COVID-19 treatment guidelines thanks to this prospective, randomized, open-label British study.
In this study principal investigators from Einstein-Montefiore compared the outcomes for two groups selected from almost 3,000 patients hospitalized at Montefiore with a positive COVID-19 test. The team treated one group of 140 patients with steroids within 48 hours of hospital admission while a control group of 1,666 similar patients didn’t receive any steroid therapy. Most of those in the intervention group were treated with prednisone while others received dexamethasone and methylprednisolone.
Multiple Steroids Can Work
Now with the study results out, Marla Keller, vice chair for research in the department of medicine at Einstein and Montefiore and lead author of the study, reports “Our study is consistent with the promising findings from Britain, but for the first time, we are able to demonstrate that people can see the same, life-saving benefits with steroid formulations other than dexamethasone.”
Dr. Keller reports that that the study team identified a prevalent blood test that could possibly serve as a kind of a biomarker, helping investigators identify the ideal patients with COVID-19 for such a steroid treatment.
The Blood Test
The liver produces C-reactive protein (CRP) in response to inflammation. Hence a common blood test with COVID-19 patients involves the CRP test, which helps investigators and care team determine inflammation levels. The higher the CRP level in the blood, the more the inflammation. For example, 0.8 milligrams per deciliter of blood or below is considered “normal” for purposes of the study.
The Einstein-Montefiore study team observed that if the CRP level is over 20 then the use of “steroids is associated with a 75% reduction in the risk of going on mechanical ventilation or dying,” reported Dr. Keller.
The Importance of this Finding
As a great number of people with COVID-19 die from surges in immune response, which overwhelms and consequently severely damages the lungs, study senior author William Southern, MD, MS, commented that “Our findings suggest that steroid therapy should be reserved for people with high inflammation, as indicated by markedly elevated CRP levels.” Dr. Southern highlighted, “It’s a different story for people who do not have significant inflammation: For them, any benefit is outweighed by the risks from using steroids.”
A Well Run, Diversified Study
The Einstein-Montefiore study was a well-run, diversified study as 40% of the patients were African American while 36% were Hispanic: the gender split was near equal reported Shitij Arora, MD, associate professor of medicine and co-author. The diverse patient population helps the investors assess whether the steroid approach can work across racial and ethnic groups for instance. The results of “the study suggests that steroid therapy benefits hospitalized COVID-19 patients affected by significant inflammation regardless of their race or ethnicity Dr. Arora reported.
Marla Keller, MD, vice chair for research in the department of medicine at Einstein and Montefiore, professor of medicine, obstetrics & gynecology and women’s’ health at Einstein, infectious disease specialist at Montefiore
William Southern, MD, MS, professor of medicine and chief of the division of hospital medicine, Einstein and Montefiore, senior author
Shitij Arora, MD, associate professor of medicine and co-author
Other authors can be viewed at the source.