BIDMC enrolling patients in clinical trials evaluating existing drug as treatment for severe COVID-19

If positive, findings could alleviate expected demand for ventilators for patients with severe COVID-19 infections.

BOSTON – Physician-scientists at Beth Israel Deaconess Medical Center (BIDMC), part of Beth Israel Lahey Health, are now enrolling patients in a clinical trial to evaluate a potential treatment of patients with COVID-19. Part of a multi-site investigation, the trial is evaluating the safety and efficacy of sarilumab, a biologic medication already approved for adults with moderately to severely active rheumatoid arthritis, for the treatment of COVID-19. Pulmonary specialist Robert Hallowell, MD, Medical Director of BIDMC’s Pulmonary Clinic, is leading the Phase 2/3 trial, which was initiated by Regeneron and Sanofi March 16, 2020.

“While the symptoms of COVID-19 are mild for many, roughly 15 percent are at risk of developing an aberrantly robust immune reaction, which in its most severe form can lead to respiratory failure and, potentially, death,” said Hallowell. “The ability to stop this reaction in its tracks would be a major step forward in the management of COVID-19, both for infected individuals and for hospitals on the front line of this pandemic.”

An inflammatory-inhibitor, sarilumab was developed by Regeneron and Sanofi to block interleukin-6 (IL-6), an immune factor called a cytokine that is involved in the overactive inflammatory response that is a common feature of autoimmune disorders like rheumatoid arthritis. The body releases cytokines including IL-6 as part of its normal immune response to injured or infected tissues. In the average person, cytokines are responsible for symptoms such as redness and swelling around a wound or infected site. In patients with autoimmune disorders, cytokines can drive the immune response that attacks otherwise healthy tissues, such as cartilage in patients with rheumatoid arthritis or the cells of the pancreas in some people with type 1 diabetes.

Similarly, an overactive inflammatory response is thought to be the cause of the lung damage and respiratory distress in a significant percentage of patients with severe COVID-19. As the immune system releases cytokines to kill the virus, infected cells in the lungs become collateral damage. In turn, this injury to the lung tissues triggers additional inflammation, and the so-called “cytokine storm” begins to spiral out of control. The result can be lasting lung damage and scarring, organ failure or death.

Designed to halt this cytokine surge, sarilumab has the potential to improve outcomes for patients with severe cases of COVID-19, as well as reduce the expected demand for ventilators — at present the only course of treatment for acute respiratory failure — for patients with severe cases of COVID-19.

“We have enrolled eight patients at BIDMC since opening the trial and plan to enroll several patients a day until the trial ends as a way of offering this potential treatment to the community,” said Hallowell, who is also an Assistant Professor of Medicine, Harvard Medical School.

Hallowell’s clinical trial is one of several efforts fostered by the BILH COVID-19 Innovation Hub, an effort led by Gyongyi Szabo, MD, PhD, Chief Academic Officer at BIDMC and Beth Israel Lahey Health to meet the emerging challenges of the COVID-19 pandemic. Other projects include research into a potential vaccine for the prevention of COVID-19, clinical trials to evaluate the antiviral medication remdesivir, and efforts to source and produce critical medical supplies and equipment.

“As of now, patients with COVID-19 receive the gold standard treatment of supportive care across our hospital system, but we continue to pursue new ways to care for them,” said Szabo. “If this drug can prevent patients from becoming gravely ill with COVID-19 or reduce the time it takes patients to recover, it could save lives.”

Hallowell's BIDMC collaborators include C. Sabrina Tan, MD, Ari L. Moskowitz, MD, Debby Ngo, MD, Noah Schoenberg, MD, Kathryn Stephenson, MD, MPH, and Gyongyi Szabo, MD, PhD.