On Wednesday, July 22, the results of a study carried out by the Albert Einstein College of Medicine and Montefiore Health System, on the use of steroid treatments in COVID-19 patients, was released and published in the Journal of Hospital Medicine. It identified the benefits and risks of steroid treatment in COVID-19 patients.

 

The study built upon a larger, earlier British steroid study, called Recovery, involving 6,000 patients. The British study found that the steroid, dexamethasone, reduced deaths from COVID-19 by about one third in patients who were on ventilators, and by about one fifth among patients who needed oxygen but who were not on ventilators.

 

The Einstein-Montefiore study went further, and answered several key questions: Which patients were most likely to benefit from steroid therapy? Could some of them be harmed [by steroid therapy]? Could other steroids substitute for dexamethasone, the steroid studied in the British trial?

 

Marla Keller, M.D. is vice chair of research at the department of medicine at Einstein and Montefiore, and was the lead author of the study. She is also professor of medicine and of obstetrics & gynecology and women’s health at Einstein, and an infectious disease specialist at Montefiore. “Our study is consistent with the promising findings from Britain,” she said, adding that, for the first time, their research was also able to show the life-saving benefits of other steroids, other than dexamethasone.

 

Keller said that earlier in the pandemic, in March and April, when less was known about COVID-19, as part of an observational study, doctors looked generally at the data for all COVID-19 patients to see if steroids could have any positive impact, knowing that they been used to treat other infections, and were known to have been successful in treating inflammation.

 

“We weren’t sure it [steroid treatment] was good for everyone,” Keller said. “We thought it might be for patients who required a lot of oxygen, or patients who had evidence of inflammation.” She added, “We looked at our data, we did an analysis, and overall didn’t see an effect on death or mortality”.

 

The researchers subsequently defined subgroups of COVID-19 patients with particular characteristics like age or levels of inflammation. “We tried to match on clinical characteristics; similar underlying medical conditions like diabetes or other conditions,” Keller said.

Watch as Einstein and @MontefioreNYC doctors Marla Keller, William Southern, and Shitij Arora explain how their new #COVID19 study results help them to better assess whether patients will benefit from or be harmed by #steroid treatment. #health #scicomm #medtwitter #pandemic pic.twitter.com/zGyQHHrgOh

— Albert Einstein College of Medicine (@EinsteinMed) July 28, 2020

 

The researchers then carried out a comparative study selecting candidates from 3,000 COVID-19 patients. One group of 140 patients was treated with steroids within 48 hours of hospital admission, while a control group of 1,666 similar patients did not receive steroids. Most of those who received steroids received the steroid, prednisone, while some received dexamethasone and methylprednisolone.

 

Keller said the highest levels of COVID-19 are present in patients very early in infection, soon after a patient is infected. Indeed, according to information from Harvard Medical School, research suggests that people may actually be most likely to spread the virus to others during the 48 hours before they start to experience symptoms.

 

According to researchers, data has shown that a large percent of the people who succumb to COVID-19 die from the body’s intense inflammatory response, which can overwhelm and severely damage the lungs. The Einstein-Montefiore comparative study found that in patients with a high level of inflammation, steroid treatment reduced the risk of dying or needing to go on a ventilator by 75 percent.

 

William Southern, M.D., M.S. is professor of medicine and chief of the division of hospital medicine at Einstein and Montefiore, and the study’s senior author. “Our findings suggest that steroid therapy should be reserved for people with high inflammation,” he said.

 

On the other hand, critically, the study also found that in patients who had normal or low levels of inflammation, steroid use increased the risk of going on mechanical ventilation or dying by 200 percent. “It’s a different story for people who do not have significant inflammation,’ said Southern. “For them, any benefit is outweighed by the risks from using steroids.”

 

Montefiore-Einstein wrote in their press release that nearly all patients in the comparative study had an initial blood test to measure their levels of inflammation prior to the study commencing. Keller said, as part of the research, she and her colleagues also found that a common blood test may identify the best COVID-19 candidates for steroid treatment.

 

As previously reported by Norwood News, Einstein and Montefiore are also participating in two large, multi-center, international, randomized COVID-19 trials of the anti-viral drug, remdesivir. That particular study comprises three phases or acts, two of which have been completed. However, only the preliminary results of the first stage are known, to date.

 

The first stage of this trial (called Act I) focused on getting COVID-19 patients out of the hospital sooner, and recovering sooner. In reference to the preliminary results of the trial in late April, Dr. Anthony Fauci, director of NIAID, said that there was reason to be optimistic about the results.

 

In a May 4 YouTube video, Dr. Barry Zingman helped viewers understand the significance of those preliminary results for hospitalized COVID-19 patients, and gave an overview of how remdesivir works in the body. Zingman is leading the trial at Montefiore Health System | Albert Einstein College of Medicine, the first site in New York to join the trial study.

 

Meanwhile, Keller said anti-viral drug treatments, like the remdesivir treatment trial, are different from steroid treatments. “Steroids – they’re more widely available and they’re inexpensive,” she said. “They can be used worldwide. Why we wanted to get our particular data out there is to help others, and other institutions understand the data so that they can also use it. I received an email this morning from Florida, asking about the paper [study findings] with some specifics.”

 

While these early research results suggest that drugs like remdesivir have been shown to improve the time to recovery in patients with COVID-19, and some steroids have shown to reduce the risk of both going on a ventilator, and of death in COVID-19 patients with high inflammation, the research continues globally in order to gather a fuller picture of which are the best treatments in given COVID-19 patient circumstances.

 

It is not straightforward and potential side effects need to be considered also. Doctors need to look at all aspects of the disease from potential lung inflammation and lack of oxygen, to immune response and clearance of the virus. While some treatments may address one factor, they may not necessarily work for others. Steroid type and dosage also needs to be considered.

 

Because inflammation is also a big factor when it comes to Multi-Symptom Inflammatory Syndrome for Children (MIS-C), the worrisome, recently identified syndrome that has been linked to COVID-19, and manifesting in some children around the world in recent months, as reported by Norwood News, we asked Keller if steroid treatment was being looked at as a way to treat MIS-C also.

 

“It’s a really important question. The multi-inflammatory syndrome that we’re seeing in kids – we do need to further understand,” she said. “The studies that we’re talking about today, “Recovery”, and our study at Montefiore had very small numbers of children.”

 

Meanwhile, study co-author, Shitij Arora M.D., associate professor of medicine at Einstein and a hospitalist at Montefiore, noted that the steroid study included approximately equal numbers of male and female patients and, in addition, nearly 40 percent of patients studied were Black, and 36 percent were Hispanic.

 

“The demographic diversity of the patients in this study suggests that steroid therapy benefits hospitalized COVID-19 patients affected by significant inflammation regardless of their race or ethnicity,” Arora said.

 

The title of the published Montefiore-Einstein paper is “Effect of Systemic Glucocorticoids on Mortality or Mechanical Ventilation in Patients With COVID-19.” Other Einstein and Montefiore authors were Jen-Ting Chen, M.D., M.S., Elizabeth Kitsis, M.D., M.B.E., Shivani Agarwal, M.D., M.P.H., Michael Ross, M.D., and Yaron Tomer, M.D.

 

*Editor’s Note: It is important to note that the referenced treatments were all carried out under the supervision of medical experts. Members of the public are reminded to consult with a trusted physician or healthcare provider in relation to health-related matters, and prior to taking any medications, including steroids.