Stony Brook Medicine Launching Clinical Trials And Enlisting Battelle Critical Care Decontamination System™

Stony Brook Medicine has announced that they have already, or will soon be introducing, multiple clinical trials that will focus on pinpointing effective therapies for critically ill patients.

Those include: “A nucleotide analogue that blocks viral reverse transcriptases, Remdesivir, developed to treat two other RNA viruses, Ebola and Marburg, has been tested and appears to be effective in treating COVID-19 in China and in Washington State. Led by Principal Investigator, Dr. Sharon Nachman, chief of the Division of Pediatric Infectious Diseases at Stony Brook Children’s Hospital, Stony Brook Medicine has administered Remdesivir to two patients thus far with severe COVID-19. Now, the team is attempting to become part of the clinical trial run by the drug’s manufacturer, Gilead Sciences; Led by Principal Investigator Dr. Bettina Fries, chief of the Division of Infectious Diseases, Stony Brook Medicine and Co-Principal Investigator Dr. Luis Marcos, associate professor of clinical medicine, they have become part of a Regeneron-sponsored clinical trial for their drug Sarilumab (Kevzara), a monoclonal antibody which blocks binding of interleukin-6 to its receptor. Sarilumab is already FDA approved for the treatment of juvenile rheumatoid arthritis, and more recently for the cytokine storm that accompanies the use of CAR-T cells for acute leukemia. The first Regeneron patient was recruited on March 30; Led by Elliot Bennet-Guerrero, Medical Director for Perioperative Quality and Patient Safety for Stony Brook Medicine, and based on similar studies in China which showed promise, SBM anticipates launching a clinical trial of donated, post-convalescent plasma from COVID-19 patients very soon, based on the level of antibody titers to SARS-CoV2 in the donor plasma. Serum or plasma therapy for infectious diseases dates to the 1890s, when serum made from immunized animals provided the first effective treatment for Clostridium tetani and Corynebacterium diphtheriae; SBU professor Lily Mujica-Parodi has been part of a national effort to employ a wearable technology device (Oura) to collect sufficient physiological data, and use deep learning algorithms to predict the onset of SARS-CoV2 infection. This type of device would be most productive and predictive in hospitals like our own where there is a large number of healthcare workers in high-risk-for-infection roles (ICUs, EDs, etc.).”

Dr. Fries, who is also a Professor of Medicine, Molecular Genetics and Microbiology, is also the force behind a new collaboration that could result in over one million additional personal protective equipment being produced each month. Her neighbor, Agjah Libohova, is an R&D specialist at a local manufacturing company, Clear-Vu Lighting. As many hospitals are turning to innovative ways to procure vital supplies, Dr. Fries reached out to Libohova to see if the manufacturing company would be able to create a prototype of the face shield that she wears. After inspecting the face shield, the University deemed the prototype fits guidelines for use in a medical facility.

Now, Clear-Vu Lighting is focused on developing a way to mass-produce the face shields, which is expected to begin by early April. The first order of 20,000 face shields will be sent to Stony Brook University Hospital. Clear-Vu Lighting expects to be able to produce 40,000 face shields per day and approximately 1.2 million per month.

Jon Longtin, a Professor in Engineering, is lending his expertise to Clear-Vu Lighting in regards to the engineering aspects of the face shield production.

Additionally, Stony Brook Medicine offered its site to utilize the Battelle Critical Care Decontamination System™ (CCDS). It will employ the CCDS to decontaminate personal protective equipment, specifically N95 masks, and render them safe to use again. Stony Brook Medicine estimates that the CCDS can decontaminate up to 80,000 masks per day, by the end of this week.

“We have men and women on the front-lines that do not have the equipment that they need to protect themselves. So this is intended to be a stop-gap. The shortage that we’re all reading about in the news is all very real. That’s why this system is so important,” Kevin Good, senior research scientist for Battelle, who is onsite, explained. “That ppe that would be otherwise discarded and not available to our healthcare providers, we can receive that material in, decontaminate it, render it safe, and return it to them. So they can have the supplies that they need to provide the services we’re asking them to.”

The N95 masks can be decontaminated up to 20 times. After that, the masks are no longer efficient and must be discarded. “As long as they come back to us in good condition – meaning no tears, no punctures, no holes, and then no soiling and no make-up, we’re able to decontaminate them, and get them back into the healthcare system,” Good noted.

A single decontamination unit can hold approximately 5,000 N95 masks per cycle. “We’ll run as many cycles as we can. It is dependent on a number of factors, including the weather conditions – so temperature and relative humidity influence how quickly we can turn a system around,” Good said.

“We’re excited to be here, we’re excited to help out,” he relayed.

For more information about Stony Brook Medicine, visit www.stonybrookmedicine.edu.