Hackensack University Medical Center has been approved by the U.S. Food and Drug Administration and Institutional Review Board to proceed with a clinical trial recruiting recovered and recovering COVID-19 patients to assess their blood and test it for antibodies in response to the virus.
These antibodies, which target and neutralize the virus, have the potential to help other patients who are infected with COVID-19. Patients with high levels of potent antibodies will be asked to come back to donate an additional blood sample, which may be helpful for sick COVID-19 patients.
If you, or someone you know, have recovered or are recovering from COVID-19, you may be eligible to donate.
Patients can find the survey here.
In the response to a COVID-19 infection, people fight off the virus by producing antibodies that attack and neutralize it. These antibodies, which are found in the blood of recovered patients, can be used to help others who are critically ill, as well to help prevent new infections. Effective antiviral therapy is crucial to defeat COVID-19.
Michele Donato, M.D., at the John Theurer Cancer Center at Hackensack University Medical Center, where the treatment is being performed, says “It really is a race against time,” People are getting sick right now, and we are working night and day to save as many lives as possible.”
Scientists at the Center for Discovery and Innovation at Hackensack Meridian Health, have developed a high-titer test to assess the presence and levels of the antibodies. The CDI experts also previously developed a diagnostic test for detecting the virus, which has been used to diagnose more than a thousand patients so far in the Hackensack Meridian Health network.
“This is applied science in ‘real-time,’ as this pandemic continues to spread,” said David S. Perlin, Ph.D., the chief scientific officer and senior vice president of the CDI. “Our scientists at the CDI are responding to an unmet medical need of the highest order, and we’re hoping to save lives.”
“Research at Hackensack Meridian Health is more important than ever, and we are hopeful it will give us the edge against this pandemic,” said Ihor Sawczuk, M.D., FACS, president of Hackensack Meridian Health’s Northern Region, and the chief research officer of the network.
The treatment theory is not new. Passive antibody therapy has been used since the 1890s to help patients survive deadly diseases for which drugs did not exist such as measles, SARS, Ebola, H1N1, flu and polio.
During the SARS outbreak in 2002-2003, an 80-person trial of convalescent serum in Hong Kong found that people treated with antibody-rich plasma within two weeks of showing symptoms had a higher chance of being discharged from the hospital than those who weren’t treated. Most recently, in China, a small uncontrolled study involving 5 people infected with COVID-19 demonstrated that it helped those in serious distress with acute respiratory distress syndrome (ARDS) – one of the hallmarks of this new scourge.
It’s called “convalescent serum” – the antibodies responding to the virus in one patient can potentially work in the bloodstream of other patients. Until new antiviral drugs or vaccines are available, this is likely the best front-line treatment available.
This therapy can work, and there is evidence it can work now.
But we need to identify the best donors for therapy, our “super donors” – people with a lot of virus neutralizing antibodies, and who are not going to still spread the virus. For this reason, we need to screen lot of virus-free survivors to find the very best candidates for successful therapy.
The funds raised will benefit research associated with this test at CDI and other innovative therapies at Hackensack Meridian Health. All donations are 100 percent tax deductible and processed by the registered 501(c)3 on behalf of Hackensack Meridian Health .
The funds raised will go directly to the cost of testing and validating serum to identify the best of the best donors for treatment and developing new therapies including drugs and a vaccine.
The work will scrutinize the antibodies within the serum of the surviving patients in an attempt to discover more about the disease, and perhaps develop new ways to fight it. Already more than half of the CDI labs are working on COVID-19 research projects, and research partnerships with major institutions and companies are underway.
The Hackensack Meridian Center for Discovery and Innovation (CDI) is an academic-based entrepreneurial center that rapidly harnesses innovations arising from biomedical sciences to improve patient health. Founded in 2019, the CDI applies science in “real-time” to get the latest advances from the laboratory bench to the clinical bedside, as quickly as possible.
John Theurer Cancer Center at Hackensack University Medical Center is New Jersey’s largest and most comprehensive center dedicated to the diagnosis, treatment, management, research, screenings, and preventive care as well as survivorship of patients with all types of cancers. Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey. John Theurer Cancer Center is a member of the Georgetown Lombardi Comprehensive Cancer Center Consortium, one of just 16 NCI-approved cancer research consortia based at the nation’s most prestigious institutions.