Montefiore and Einstein Begin Clinical Trial for Severely Ill COVID-19 Patients

(BRONX, NY)—April 3, 2020—Montefiore Health System and Albert Einstein College of Medicine has started treating very sick COVID-19 patients as part of a multicenter trial evaluating a potential therapy for the new disease. The double-blind, placebo-controlled trial is testing whether sarilumab, a drug already approved for treating rheumatoid arthritis, can halt the inflammation that can overwhelm the lungs of COVID-19 patients. A very similar drug yielded promising results in a recent study involving patients in China.

“Of all the COVID-19 studies that have come across my desk, that study from China seems the most promising,” said Michelle Gong, M.D., who leads the Montefiore-Einstein effort. “We’re all desperate to find something that can help these patients.” Dr. Gong is professor of medicine and of epidemiology & population health, chief of the divisions of pulmonary medicine and of critical care, and director of critical care research at Montefiore and Einstein.

Of all the COVID-19 studies that have come across my desk, that study from China seems the most promising.

Michelle Gong, M.D.

The Chinese study found that severely ill COVID-19 patients have high blood levels of IL-6, an inflammatory protein thought to be responsible for patients’ severe and often fatal lung inflammation. Sarilumab and the drug used in the Chinese study (called tocilizumab) are monoclonal antibodies that both work by blocking IL-6 from latching onto cells and causing inflammation. Both drugs are administered intravenously.

Montefiore and Einstein is among dozens of sites evaluating sarilumab (sold under the name Kevzara) in what’s called a phase 2/3 trial. Patients qualifying for the trial must have pneumonia and fever and be hospitalized with laboratory-confirmed COVID-19. They must also be considered in severe or critical condition or be suffering from multi-organ dysfunction.

In the first or phase 2 part of the trial, patients will be randomized in a 2:2:1 ratio into three groups: sarilumab high dose, sarilumab low dose, and a placebo group. Patients in all groups will receive usual supportive care for COVID-19, which includes oxygen, blood pressure management, ventilator support, and antibiotics. Patients will be assessed for 60 days, or until hospital discharge or death.

“We’d like to be able to see patients’ fevers come down pretty quickly and for them to have less need for oxygen,” says Dr. Gong. She notes that the trial has an adaptive design, meaning she and other trial leaders have the flexibility to take knowledge gained from phase 2—regarding drug dosage or characteristics of patients who may be responding to the drug, for example—and apply it to phase 3, which will include more patients than the phase 2 part of the trial.

Dr. Gong notes that there is no limit to the number of patients that trial sites can treat. “We’re enrolling as many patients as we can,” she says.