May 22, 2020 Trinitas Researchers Take on COVID-19 Clinical Trials


As the COVID-19 pandemic continues to challenge health care professionals, Trinitas Regional Medical Center physicians are working to save lives with cutting-edge treatments and clinical trials.

Perhaps the toughest challenge of the disease has been acute respiratory distress syndrome (ARDS) and respiratory failure, which are trademarks of progressive COVID-19. And although a broader understanding of the virus is coming to light, there remains an enormous need for novel therapies before the battle can be won.

“We’re proud to lend our research talents and resources to the campaign to halt and treat COVID-19,” says Gary S. Horan, President & CEO of Trinitas. “Our physicians and researchers are more than up to this task.”

Trinitas was among the first to use a stem cell therapy developed by Vitti Labs, an FDA-registered tissue bank specializing in cellular and decellularized products for human transplant and cosmetic use in clinical setting. Currently, seven patients have participated in this novel research project. There are several doctors overseeing their treatments as part of an interdisciplinary team. Dr. Gerardo Capo, MD, Division Chief of Hematology, and Dr. John D’Angelo, DO, Chair of Trinitas Regional Medical Center’s Emergency Services, are Co-Principal Investigators, while Dr. Michelle Cholankeril, MD, Division Chief of Medical Oncology; Dr. Barry Levinson, MD, Medical Director of the Trinitas Comprehensive Cancer Center, and Dr. Vincent Salerno, MD, are Sub-Investigators.

Dr. Rassam Khan, MD, Research Associate has been involved with ensuring all treatments are being performed according to study protocol, while performing much of the hands-on work with the stem cells.

Lisa Paternoster, CCRA, CCRP, Research Manager, who worked to get the study up and running at Trinitas, says, “The hematologists/oncologists and the head of Emergency Medicine at Trinitas have really stepped up to the plate to volunteer to be Investigators on this cutting-edge study using stem cells to fight the disease. They are not infectious disease specialists, however, the experience these doctors have in conducting prior research have made them the perfect candidates to take on this huge endeavor.”

Dr. Cholankeril, the division chief of medical oncology at Trinitas Comprehensive Cancer Center, who is overseeing a process sponsored by the Mayo Clinic through the American Red Cross, says, “This pandemic has presented new challenges like we’ve never seen before, but we have already seen some positive responses with a subgroup of our plasma patients.”

Patients with COVID-19 are infused with antibody rich plasma from coronavirus survivors to help fight the virus. To date, more than 40 patient requests have been approved to participate, and 17 have already been infused. Dr. Cholankeril adds, “Thanks to the Mayo Clinic and Red Cross, we are now able to have survivors help ailing patients. In the time of a pandemic, there is no better way to show support for one another than to donate one’s own plasma.”

In an investigational setting, Trinitas is also looking at the effectiveness of a drug typically used to treat rheumatoid arthritis and the cytokine storm that can occur with certain cancer treatments. The interleukin-6 (IL-6) inhibitor drug, Tocilizumab, also known as Actemra®, has been used to treat 60 patients at Trinitas. “We are looking to see if a lower dose of tocilizumab will combat the cytokine storm seen in COVID-19,” says Dr. Cholankeril. “We are already seeing exciting, positive results in newly diagnosed COVID-19 patients that are on non-invasive oxygen ventilation.”

Dr. Cholankeril is also the Principal Investigator for the “Expanded Treatment Access study for SARS-CoV2 infection” sponsored by Gilead. The study is of Remdesivir, an antiviral drug available to patients that meet certain criteria.

“The first of five COVID-19 patients has already started the planned10-day infusion treatment,” says Dr. Cholankeril. “We have high hopes for positive results in this group of patients, as they continue to be a challenging group to manage.”

Contact Information

Doug Harris

Yolanda Fleming