Rutgers Cancer Institute of New Jersey is participating in a COVID-19 study investigating whether azithromycin (Zithromax) combined with hydroxychloroquine (Plaquenil) is better than hydroxychloroquine alone as a possible treatment for patients diagnosed with COVID-19. The sites include Rutgers Cancer Institute, Robert Wood Johnson University Hospital in New Brunswick, and University Hospital in Newark. The clinical trial is not limited to patients with cancer.
The Study Drug
Numerous clinicians are treating COVID-19 patients with hydroxychloroquine and even the president of the United States, Donald Trump, suggested the drug was a “game changer.” But there is not scientific proof that the drug works to reduce the effects of SARS-CoV-2. Hence, presently there are over 60 studies investigating the use of hydroxychloroquine in COVID-19 patients. Dr. Steven K. Libutti, director of the Rutgers Cancer Institute, noted on this point: “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.” Dr. Libutti, who also serves a vice chancellor of cancer programs at Rutgers Biomedical and Health Sciences, noted, “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,” reports Hannah Slater with CancerNetwork.
Azithromycin was approved by the FDA for the treatment of infections, while hydroxychloroquine is approved by the FDA for the treatment of malaria and autoimmune diseases, such as lupus and rheumatoid arthritis. Presently, there is no antiviral therapy accepted by the FDA targeting COVID-19.
The Méditerranée Infection Study in France
CancerNetwork reports on a recent French single-arm study of hydroxychloroquine and azithromycin in patients confirmed to have COVID-19, patients were administered 600 mg of the drug daily while the investigators also measured viral load daily using nasopharyngeal swabs in a hospital. The study was conducted by Méditerranée Infection, a French research institute targeting infectious disease. In the study, the team in some cases added azithromycin if circumstances warranted. The team included untreated patients as well as some patients who refused the protocol as negative controls. Using an endpoint defined as the presence and absence of virus at day 6, post inclusion, the French team treated 20 patients as part of the study. The results were promising: the investigators discovered a significant reduction of the viral carriage at day 6-post inclusion compared to the control group, reported CancerNetwork, and much lower average carrying duration than found with the untreated patients in the literature. The Méditerranée Infection investigators found that the use of azithromycin and hydroxychloroquine was found to be significantly more efficient for virus elimination.
Summarizing the Méditerranée Infection findings, the authors touted, “We therefore recommend that COVID-19 patients be treated with hydroxychloroquine and azithromycin to cure their infection and to limit the transmission of the virus to other people in order to curb the spread of COVID-19 in the world.” They concluded: ““Further works are also warranted to determine if these compounds could be useful as chemoprophylaxis to prevent the transmission of the virus, especially for healthcare workers.”
The New Jersey Study
At Rutgers, the investigators will recruit patients 18 and older who have been diagnosed with COVID-19 and meet the inclusion criteria, but any individuals seeking to participate must also past a battery of tests. Eligible participants will be assigned randomly, reports CancerNetwork, to either azithromycin and hydroxychloroquine, hydroxychloroquine alone, or supportive care for 6 days followed by hydroxychloroquine. This treatment will continue for 10 days and patients are thereafter followed for six months.
Lead Researcher/Investigator at Rutgers
Dr. Steven K. Libutti, Director, Rutgers Cancer Institute