Rutgers Cancer Institute of New Jersey has announced that they will be offering a clinical trial exploring whether azithromycin (Zithromax) combined with hydroxychloroquine (Plaquenil) is better than hydroxychloroquine alone as a potential treatment for patients diagnosed with coronavirus disease 2019 (COVID-19).1
The trial is being offered at Rutgers Cancer Institute, Robert Wood Johnson University Hospital in New Brunswick, and University Hospital in Newark. Additionally, the trial is not limited to patients with cancer.
“Whiles 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,” Rutgers Cancer Institute Director Steven K. Libutti, MD, FACS, who is also senior vice president of oncology services at RWJBarnabas Health and vice chancellor of cancer programs at Rutgers Biomedical and Health Sciences, said in a press release. “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.”
Patients aged 18 and older who have been diagnosed with COVID-19 and meet other criteria may be eligible to participate in the trial. However, prior to being accepted into the clinical trial, individuals must undergo a number of tests including bloodwork and a physical exam.
Once deemed eligible, participants will be assigned randomly to either azithromycin and hydroxychloroquine, hydroxychloroquine alone, or supportive care for 6 days followed by hydroxychloroquine. Overall, the treatment will continue for 10 days; once completed, participants will be followed monthly for 6 months to monitor for the return of any symptoms.
Currently, there is no standard antiviral therapy that is approved by the FDA for the treatment of individuals infected 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, including lupus and rheumatoid arthritis.
In a French single-arm study of hydroxychloroquine and azithromycin in patients confirmed to have COVID-19, patients received 600 mg of hydroxychloroquine daily and researchers tested their viral load in nasopharyngeal swabs daily in a hospital setting.2 Depending on the clinical presentation of participants, azithromycin was also added to their treatment.
Untreated patients from another center and patients who refused the protocol were included in the study as negative controls. The presence and absence of virus at day 6, post-inclusion, was considered to be the endpoint for the analysis.
Overall, 20 patients were treated in the study, which demonstrated a significant reduction of the viral carriage at D6-post inclusion compared to controls, and much lower average carrying duration than reported of untreated patients in the literature. In cases where azithromycin was added to hydroxychloroquine, the combination was found to be significantly more efficient for virus elimination.
“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,” the study authors wrote. “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.”
1. Rutgers Cancer Institute Offers Clinical Trial Examining Potential Treatment for COVID-19 [news release]. New Brunswick, New Jersey. Published April 3, 2020. cinj.org/rutgers-cancer-institute-offers-clinical-trial-examining-potential-treatment-covid-19. Accessed April 7, 2020.
2. Gautret P, Lagier J, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. International Journal of Antimicrobial Agents. doi:10.1016/j.ijantimicag.2020.105949.