Danbury and Norwalk hospitals, in addition to Vassar Brothers Medical Center in Poughkeepsie, all part of Nuvance Health, were selected by the COVID-19 Plasma Trial, sponsored by Johns Hopkins in partnership with American Red Cross and Bloomberg Philanthropies to participate in important COVID-19 research. A pair of pivotal national convalescent plasma clinical trials comes to what was formerly known as Western Connecticut Health Network, now part of Nuvance Health and this part of the northeast in western Connecticut and the mid-Hudson Valley.
Recently covered in a Connecticut local media called NewsTimes, the study sponsors recruit 1,100 people from across the nation so that the investigators can determine if convalescent plasma therapy, recently approved for emergency use authorization by the U.S. FDA, can be used to effectively treat individuals infected with early-stage SARS-CoV-2 or actually prevent disease progression in high risk participants, that is those at risk for exposure at home or at work (e.g. first responders, etc.).
Nuvance Health Perspective
Joann Petini, PhD, vice president of innovation and research for Nuvance, recently stated, “We are very excited to be able to offer these national studies to our local communities.” Petini emphasized Nuvance Health’s research mission, touting, “This is one of the many ways that Nuvance Health is working to combat the devastating impact of COVID-19.”
COVID-19 Plasma Trials
The study is actually part of an entire program sponsored by Johns Hopkins Called the COVID-19 Plasma Trials. They include two studies, including 1) COVID-19 Positive Trial and 2) COVID-19 Exposed Trial.
The COVID-19 Positive Trial assesses if an infusion of plasma containing antibodies from people who have recovered from COVID-19 can prevent others from getting infected. Getting plasma with COVID-19 antibodies may protect humans against COVID-19 infection, however the study is required to evaluate and confirm this premise. While the COVID-19 Exposed trial seeks people who have been exposed to someone with confirmed COVID-19, but do not yet have any symptoms. If this trial proves to be successful, this treatment could help other people, who get exposed to the disease in the future, to not develop symptoms and possibly reduce the need for hospitalization.
The clinical trial sites are distributed across the United States, including, of course, this part of the northeast.
NewsTimes reports that the local hospitals are seeking participants, that is those who may have been exposed in their home or at work as health care providers. For the companion trial participants must participate within 8 days of their first symptoms but not ill to the extent of needing hospitalization.
The participants will receive one intravenous infusion of the convalescent plasma that contains antibodies for COVID-19 or placebo plasma that doesn’t contain the antibodies. This infusion will be administered at an outpatient facility and typically takes an hour or so. Participants must be over 18. Study teams at Nuvance Health will evaluate those participants exposed to the pathogen over four weeks for development of infection. These checks include symptom checks and laboratory testing. They’ll be monitored for a month to assess the course and severity of the disease. Additionally the researchers will probe long-term immunity of both study groups at three months post infusion.
Nuvance Health is a regional health system in Connecticut and New York State that now serves 1.5 million individuals across the mid-Hudson Valley and western Connecticut. The hospitals involved used to be part of the Western Connecticut Health Network but they joined Nuvance Health, a non-profit group of three Western Connecticut hospitals formed in 2010 by Danbury Hospital, New Milford Hospital and Norwalk Hospital. The health system manages a robust research unit known as Rudy L. Ruggles Biomedical Research Institute at Western Connecticut Health Network.
The research team is led by Ms. Petini mentioned above as well as Sandra Lobo, PhD.
Call to Action: Patients, if you reside in this part of New York or Connecticut and are interested in participating, consider speaking with your physician and contacting Nuvance Health. For more information on the plasma trials and eligibility, contact: COVID19plasmaStudy@nuvancehealth.org or call 203-739-7341 TTY: 800-842-9710 in Connecticut or 845-230-1411 TTY:800 421-1200 in New York.
Sponsors and CROs, if you are doing research in the northeast consider learning more about Nuvance Health’s Ms. Lobo at 203-739-8388 or Sandra.email@example.com