Montefiore Health System and Albert Einstein College of Medicine announced on May 21 that they 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.

Doctors are hopeful that the drug being trialled, leronlimab, may prevent an inflammatory condition that fatally damages the lungs and other organs in many COVID-19 patients.

Both hospitals were also the first sites in New York State to begin trials of the drug, remdesivir, in COVID-19 patients, as reported previously by Norwood News. Dr Anthony Fauci, a senior member of the White House coronavirus task force, said in recent weeks that there was reason to be optimistic about the initial results of the remdesivir clinical drug trials in treating patients of COVID-19.

Harish Seethamraju, M.D., an organ transplant specialist and a member of the department of medicine at Montefiore and Einstein, researched leronlimab early in the pandemic, and realized its potential for treating his transplant patients who had COVID-19.

Seethamraju said that the Leronlimab trial is different from the remdesivir drug trial in that remdesivir cannot be given to patients with renal and liver damage, but leronlimab can.

“In the beginning of our work with leronlimab, we were using this medication with select patients under the FDA’s Emergency Investigational New Drug use. All of the patients who received leronlimab at this time were critically ill and did not qualify for the remdesivir trial,” he said.

Seethamraju said that Leronlimab is an antibody with minimal side effects. “It has a good safety profile,” he said, explaining that due to its constitution, leronlimab increases the likelihood that the body’s immune cells can clear the virus safely and more effectively.

Following his initial analysis of the drug, he obtained “compassionate use” permission from the FDA so that he and his colleagues could use leronlimab on ten severely ill COVID-19 patients, six of them transplant patients from various organ transplant programs.

“By calming the overactive immune systems of these patients, leronlimab halted the inflammation and blood clotting that are so damaging to the lungs, liver and kidneys of severely ill COVID-19 patients,” said Seethamraju.

On May 5, a study describing promising results for those ten 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 Seethamraju, the study reported that five of the ten 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 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 are participating in this latest phase.

“Such patients all too often seem to be recovering, but then crash and burn when their lungs are overwhelmed by an inflammatory reaction that makes breathing impossible,” said Seethamraju. “The FDA is concerned that there is no treatment for those people.”

Patients in the multi-center second phase 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.

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 16, Montefiore enrolled the first patient in the 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.

A double-blind study or trial is one in which neither the participants nor the experimenters know who is receiving a particular treatment.

The 390 patients taking part in the now multi-center 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.

A placebo is a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect. The trial will evaluate the patients’ survival at 14, and at 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 an antibody drug developed by CytoDyn Inc., a biotechnology company based in Vancouver, Washington state.

According to a report by Fox news, in April, the FDA has granted CytoDyn Inc. a “fast-track” designation for two potential uses of leronlimab: as a combination therapy with other medications for HIV patients, and for patients with metastatic triple-negative breast cancer.

*Editor’s Note: Readers are reminded that the referenced drugs in this article are all being tested in a clinical setting under the supervision of medical experts. Readers are reminded to consult with a trusted physician in relation to health related matters, especially in relation to drugs of any kind.

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Welcome to the Norwood News, a bi-weekly community newspaper that primarily serves the northwest Bronx communities of Norwood, Bedford Park, Fordham and University Heights. Through our Breaking Bronx blog, we focus on news and information for those neighborhoods, but aim to cover as much Bronx-related news as possible. Founded in 1988 by Mosholu Preservation Corporation, a not-for-profit affiliate of Montefiore Medical Center, the Norwood News began as a monthly and grew to a bi-weekly in 1994. In September 2003 the paper expanded to cover University Heights and now covers all the neighborhoods of Community District 7. The Norwood News exists to foster communication among citizens and organizations and to be a tool for neighborhood development efforts. The Norwood News runs the Bronx Youth Journalism Heard, a journalism training program for Bronx high school students. As you navigate this website, please let us know if you discover any glitches or if you have any suggestions. We’d love to hear from you. You can send e-mails to norwoodnews@norwoodnews.org or call us anytime (718) 324-4998.