Rutgers Launches Azithromycin, Hydroxychloroquine Clinical Trial

NEW BRUNSWICK, NJ – On Friday, researchers at the Rutgers Cancer Institute of New Jersey started a groundbreaking clinical trial exploring if azithromycin combined with hydroxychloroquine is an effective treatment for coronavirus/covid-19.

Azithromycin is a bacterial antibiotic with the common brand names Zithromax/Z-Pak. Hydroxychloroquine is an anti-malarial drug that has been around for decades; it commonly goes by the brand name Plaquenil. Hydroxychloroquine is also used for auto-immune diseases, such as lupus and rheumatoid arthritis.

Specifically, the Rutgers Cancer scientists are researching if the combination of the two, azithromycin combined with hydroxychloroquine, is better for covid-19 than simply hydroxychloroquine alone.

The clinical trial started this past Friday, April 3. It will enroll 160 covid-19 patients currently being treated at Rutgers Cancer Institute, Robert Wood Johnson University Hospital in New Brunswick, and University Hospital in Newark. Those patients must meet specific criteria to be included in the trial.

On March 26, Patch interviewed this Manalapan woman who was hospitalized with pneumonia from covid-19. She was given a combination of hydroxychloroquine and azithromycin, and said she "turned a corner" at that point.

"I think they really don't know yet what works," the patient, Margaret Novins, 53,told Patch. "But I can say the first thing they gave me was the Plaquenil and azithromycin, and I definitely turned a corner at that point."

In addition to those two drugs, Novins was also given anti-viral HIV medication and remdesivir, a drug originally developed to treat Ebola. Doctors have been prescribing Plaquenil and azithromycin as off-label treatments for coronavirus, but scientists and researchers say there is a strong need for clinical trials.

To be part of the Rutgers Cancer Institute trial, patients must be 18 and older, diagnosed with covid-19 and meet other criteria to 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 six 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.

For information on how to take part in this clinical trial, individuals should call Rutgers Cancer Institute’s Office of Human Research Services at 732-235-7356 or email statewide_research@cinj.rutgers.edu.

The trial has been fast-tracked largely because Rutgers has the infrastructure and expertise to carry it out. It will be overseen by Rutgers Cancer Institute Director Dr. Steven Libutti, who is also senior vice president of oncology services at RWJBarnabas Health.

There is no standard FDA-approved treatment for covid-19/coronavirus. Experts have repeatedly pointed to the imperative need for a controlled clinical trial with a large patient population to determine the efficacy of plaquenil and azithromycin.

“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," said Dr. Libutti.

Two weeks ago, the federal government gave New York state clearance to start giving a Plaquenil/azithromycin combination to covid-19 patients. At around the same time the World Health Organization approved a groundbreaking "global mega-trial" to see if remdesivir, chloroquine/hydroxychloroquine and an HIV drug combo can effectively fight covid-19, according to Science magazine.

Related: Manalapan Woman Given Experimental Drugs, Survives Coronavirus (March 26, 2020)