Nuvance seeking COVID-19 patients for clinical trial
SHARON — Anyone who has been exposed to or diagnosed with COVID-19 and did not require hospitalization may be eligible to take part in clinical studies examining both the treatment and prevention of the virus.
Nuvance Health is seeking volunteers through the early fall of this year to participate in two clinical trials to test the effectiveness of convalescent blood plasma for outpatient COVID-19 study intervention. The trials aim to recruit 1,100 people from across the country to help researchers determine if convalescent blood plasma therapy can effectively be used to treat people in the early stages of COVID-19 illness or prevent the infection in those at high risk of exposure to the virus at their homes or jobs.
Nuvance Health was selected by Johns Hopkins to offer these studies at Danbury Hospital and Norwalk Hospital in Connecticut and Vassar Brothers Medical Center in Poughkeepsie, N.Y.
The study intervention is a transfusion of a blood product from COVID-19 survivors that contains antibodies that may help the patient’s immune system fight the virus.
“Preliminary studies on convalescent plasma use in severely ill, hospitalized patients have shown that convalescent plasma is safe,” said Joann Petrini, PhD, vice president of Innovation and Research at Nuvance Health. “These new studies will test whether a transfusion of plasma containing antibodies from persons who have recovered from COVID-19 is an effective treatment for patients with early illness and a way to prevent the infection among those who have been exposed to the virus.”
People who may be eligible for the prevention trial are those who have been exposed to COVID-19 in their home or at work as healthcare providers.
For the companion trial, participants will have been diagnosed with early COVID-19 disease, meaning they are within eight days of their first symptoms but are not sick enough to be in a hospital.
All participants will be over age 18.
Participants will receive one IV infusion of the convalescent plasma that contains antibodies for COVID-19 or placebo plasma that does not contain the antibodies, at an outpatient facility, which usually takes about an hour.
As part of the trials, participants who have been exposed to the virus will be evaluated over four weeks for development of COVID-19 infection, including symptom checks and laboratory testing for the virus and antibodies.
Participants with COVID-19 will be monitored over four weeks to determine the course of the disease and its severity. The researchers will examine the long-term immunity of both groups at three months after infusion with convalescent or placebo plasma.
There are no FDA-approved vaccines to prevent infection with the SARS-CoV-2 virus, which causes COVID-19 disease, nor approved study interventions for the illness in its earliest stage. Currently, only hospitalized patients have access to any type of therapy for COVID-19.
There are no other outpatient therapies to prevent hospitalization or death.
Physicians have used the study intervention for severe diseases in hospitals for more than a century, often during epidemics such as the influenza pandemic of 1918 and the more recent outbreak of severe acute respiratory syndrome (SARS) in 2003. Laboratory experiments in the past have shown that the therapy neutralizes many viruses.
For more information on the plasma trials and eligibility, email 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.