A new drug trial treatment is underway at the Moses Campus of Montefiore Health System using the experimental drug, remdesivir, which might help patients with serious COVID-19 complications. The Montefiore site is the first one to open in New York State as part of an international multi-center effort to fight the deadly disease which has taken close to 60,000 lives worldwide since it was first detected in December 2019 in Wuhan, China. 

 

According to a press release, Montefiore Health System, in conjunction with the Albert Einstein College of Medicine, has joined an international clinical trial which is taking place across 46 testing sites nationwide and internationally to evaluate remdesivir to see if, potentially, it helps those hospitalized with serious lung complications, and severe COVID-19 infection. The National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring the trial, for which candidate recruitment began in March and is currently ongoing. 

 

NIAID launched the multi-center international effort to determine if remdesivir, a broad-spectrum antiviral drug, developed by Gilead Sciences, Inc., will be successful in combatting the COVID-19 viral infection. The drug has shown promise in animal models of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), both caused by human coronaviruses.

 

Barry Zingman, M.D., professor of medicine at Einstein and clinical director, infectious diseases, in the Moses division of Montefiore Health System, is the principal investigator leading the trial and said it is, “adaptive”, meaning it can be modified to include other investigative treatments. “This flexibility allows us to add additional therapies to the trial step-by-step to improve treatment as the pandemic continues,” his statement read. 

 

The type of lung complications which trial participants have include rattling sounds when breathing, a need for supplemental oxygen, abnormal chest X-rays showing pneumonia, or the need for a mechanical ventilator. Patients in the treatment group will receive 200 mg of remdesivir intravenously on the first day of their enrollment in the study, and will receive another 100 mg each day for the duration of hospitalization, for up to ten days in total.

 

Montefiore and Einstein’s robust clinical trial infrastructure contributed to its selection and rapid approval for trial participation. Hopes are high that the overall trial will be successful since to date, no vaccines or therapies have yet been approved by the FDA for treating the coronavirus.

 

Remdesivir is already FDA approved, though not for COVID-19. A spokesperson for Montefiore who shared the press release said, “This is a double-blinded trial to see if it is safe and efficacious”. She confirmed that about 30 people at Einstein are enrolled thus far in the trial, representing approximately one out of ten remdesivir clinical trial participants worldwide.

 

In response to a request for comment on the local drug trial efforts, Bronx Assemblyman Jeffrey Dinowitz said he was more focused on the day-to-day challenges facing the community, such as unemployment claims and the lack of mail delivery. “I am happy to leave the medical research to the scientists and doctors,” he said. “Whatever we need to do to save lives I am in support of, whether that is researching new drug treatments or a vaccine or whatever.” He added, “I am so proud of each and every person that has continued to go to work – whether they are treating patients, cleaning hospitals, feeding people, or researching new drugs to treat COVID-19.”

 

*An earlier version of this story stated that the physical trials were taking place at Einstein College. This has since been corrected to reflect that they are physically being carried out at the Moses campus of Montefiore Health System, and the research and analysis is being carried in conjunction with Einstein college.