On May 21, 2020, Montefiore Health System and Albert Einstein College of Medicine were the first sites in the nation to begin evaluating an investigational drug in two separate, FDA-approved trials: one to treat mild-to-moderate cases of COVID-19 and the other to treat severely ill COVID-19 patients.

On May 5th, a study describing promising results for those 10 severely ill patients was made public on the website, MedRxiv, a resource especially useful during the COVID-19 pandemic to make research quickly available to the scientific community. Co-authored by Dr. Seethamraju, the study reported that five of the 10 patients treated with leronlimab survived; the study also described the drug as “a novel approach” to resolving unchecked inflammation.

Based on the positive results with those patients, the FDA approved Dr. Seethamraju’s application for a phase 2 trial of leronlimab. That trial began enrolling both inpatients and outpatients with mild-to-moderate COVID-19 on April 2. A total of 75 will participate.

Patients in the multicenter trial receive two injections, one week apart, of either leronlimab or a placebo and are assessed periodically over six weeks for fever, muscle pain, difficulty breathing and cough. Dr. Seethamraju is a co-principal investigator of the Montefiore trial site, along with Scott A. Scheinin, M.D., surgical director of advanced pulmonary failure and lung transplantation, division chief of thoracic surgery and surgical oncology, and director of the Bloodless Heart Surgical Program at Montefiore.

On April 16th, Montefiore enrolled the first patient in a second FDA-approved leronlimab clinical trial: a randomized, double blind trial to assess the optimal dose, safety and effectiveness of leronlimab in treating severely ill COVID-19 patients. The 390 patients taking part in this multicenter trial will receive two weekly doses of either leronlimab or a placebo; there will be twice as many patients receiving leronlimab as those receiving the placebo. The trial will evaluate the patients’ survival at 14- and 28-days following treatment.

The two leronlimab clinical trials are being conducted under the direction of the departments of cardiothoracic surgery and medicine at Montefiore and Einstein. Leronlimab is a monoclonal antibody drug developed by CytoDyn, a biotechnology company based in Vancouver, WA.

Montefiore Health System is one of New York’s premier academic health systems and is a recognized leader in providing exceptional quality and personalized, accountable care to approximately three million people in communities across the Bronx, Westchester and the Hudson Valley. It is comprised of 11 hospitals, including the Children’s Hospital at Montefiore, Burke Rehabilitation Hospital and more than 200 outpatient ambulatory care sites. The advanced clinical and translational research at its medical school, Albert Einstein College of Medicine, directly informs patient care and improves outcomes. From the Montefiore-Einstein Centers of Excellence in cancer, cardiology and vascular care, pediatrics, and transplantation, to its preeminent school-based health program, Montefiore is a fully integrated healthcare delivery system providing coordinated, comprehensive care to patients and their families.