Potsdam researchers taking part in clinical trial with hospitalized COVID-19 patients
POTSDAM -- St. Lawrence Health System’s Department of Clinical and Rural Health Research is taking part in a clinical trial for hospitalized patients with COVID-19 pneumonia.
Under the guidance of Canton-Potsdam Hospital rheumatologist and principal investigator Dr. Eyal Kedar, the research department has officially opened a Phase-3 clinical trial investigating tocilizumab (marketed under the brand name Actemra).This multi-center trial is sponsored by Genentech and aims to enroll 375 patients who are hospitalized with COVID-19 pneumonia at sites across the nation. St. Lawrence Health System says they were the only rural site in New York selected for participation in the trial.
“Tocilizumab is an interleukin 6 receptor inhibitor that is approved for use in rheumatoid arthritis, giant cell arteritis, and CAR-T induced cytokine release syndrome. It is being studied as a possible treatment for hospitalized patients with COVID-19 pneumonia,” Dr. Kedar said in a news release from SLHS.
Patients enrolled in the trial will receive one intravenous (IV) infusion of either tocilizumab or placebo, and up to one additional infusion may be given, as clinically indicated. The primary outcome measure for the trial is to investigate the proportion of participants requiring mechanical ventilation by day 28.
Research Department Manager Carly Lovelett said that inpatients at Canton-Potsdam Hospital who have COVID-19, and meet criteria outlined by the research protocol, will be presented with the option of enrolling in the clinical trial.
“Before receiving treatment on the trial, the patient must go through the informed consent process and the screening process. This is to ensure the patient understands the trial and the potential risks and benefits of it, and that he/she meet the enrollment criteria,” she said in the release.
“Participation in this clinical trial is voluntary, and patients may stop participating at any point for any reason. This is true for the inpatient COVID-19 trial, along with the trials we conduct in an outpatient setting,” Lovelett said. “In the past five years, over 150 patients have volunteered to be screened for research studies across St. Lawrence Health System. Rural areas are often underrepresented in clinical research, so these patients have given the North Country a voice in research and have made a meaningful contribution to the medical field.”
The SLHS research department and Dr. Kedar are also in the process of developing a variety of other new COVID-19 trial opportunities for both hospitalized and non-hospitalized COVID-19 patients.
“COVID-19 has given fresh exposure to a longstanding healthcare gap in rural areas,” Kedar said. “In many rural hospitals, there is a shortage of medications and expertise for treating COVID-19. Between our dynamic inpatient COVID-19 treatment team at CPH and our excellent research department, we’re prepared in the St. Lawrence Health System to take care of the COVID-19 patients of our county.”
In addition to its COVID-19 trials program, the research department is also conducting several other trials at this time:
• Rheumatology: Ankylosing spondylitis, psoriatic arthritis, non-radiographic axial sponydloarthritis, systemic lupus erythematosus
• Cardiology: two trials in Paroxysmal Supraventricular Tachycardia (PSVT)
• Pulmonology: Asthma
Dr. Kedar has been the principal investigator for 13 industry-sponsored clinical trials, as well as several investigator-initiated research projects of his own design. His COVID-19 efforts were recently featured in the New York Times (https://www.nytimes.com/interactive/2020/world/coronavirus-health-care-w...).
The Department of Clinical and Rural Health Research page, along with info on how to become involved in a clinical trial, is online at https://www.stlawrencehealthsystem.org/clinical-research.
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