New Brunswick-based Rutgers Cancer Institute of New Jersey, a National Cancer Institute-designated Comprehensive Cancer Center, is offering a clinical trial as a potential treatment for patients diagnosed with the coronavirus (COVID-19). The trial, which is being offered at Rutgers Cancer Institute, Robert Wood Johnson University Hospital in New Brunswick, and University Hospital in Newark, is not limited to cancer patients.
There is no standard antiviral therapy approved by the Food and Drug Administration (FDA) for the treatment of people with COVID-19. At present clinical management includes infection prevention, control measures and supportive care. Researchers at Rutgers Cancer Institute are exploring if azithromycin combined with hydroxychloroquine is better than hydroxychloroquine alone for treatment of patients with COVID-19. Azithromycin is approved by the FDA for the treatment of infections. Hydroxychloroquine is approved by the FDA for the treatment of malaria and auto-immune diseases, such as lupus and rheumatoid arthritis.
“While some practitioners across the state have been offering this type of treatment for some individualized cases, it is imperative that a controlled clinical trial with a large patient population take place in order to ensure the integrity of the results being gathered. As a National Cancer Institute-designated Comprehensive Cancer Center, Rutgers Cancer Institute of New Jersey has the infrastructure and expertise to carry out this clinical trial,” notes Rutgers Cancer Institute Director Steven K. Libutti, MD, FACS, who is also senior vice president, oncology services, RWJBarnabas Health and vice chancellor, cancer programs, Rutgers Biomedical and Health Sciences.
Patients aged 18 and older who are diagnosed with COVID-19 and meet other criteria may be eligible to participate. Prior to being accepted into the clinical trial, participants are required to undergo a number of tests including bloodwork and a physical exam.
Eligible participants will be assigned randomly (by chance) into three groups: 1) azithromycin and hydroxychloroquine; 2) hydroxychloroquine alone; or 3) supportive care for 6 days followed by hydroxychloroquine. Treatment will continue for 10 days. Once treatment is completed, participants will be followed monthly for six months to monitor for return of symptoms.
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