Rutgers Starts Coronavirus Trial Seeking Newly Infected Patients

NEW BRUNSWICK, NJ — Rutgers is launching a new coronavirus trial that has the goal of preventing COVID-19 symptoms before they worsen or even appear, with the ultimate aim of preventing COVID patients from having to go the hospital at all.

The trial is looking to enroll New Jersey residents who have just been diagnosed with COVID, and who have no symptoms, or very mild to moderate symptoms. The study will enroll 70 participants total; 35 of those will receive a placebo.

"Up to this point, we have been largely telling people diagnosed as positive to go home, quarantine, stay away from family and hope they don't get sicker," said Dr. Jeffrey Carson, the Rutgers physician in charge of the trial. "But the goal of this trial is to see if we can come up with a combination of medicine that will prevent them from getting sicker."

The trial, called Triple Combination Antiviral Coronavirus Therapy (TriACT), was just announced Monday. Rutgers is seeking people who have been diagnosed with SARS-CoV-2 within the previous six days, preferably within the last two days and are asymptomatic or mildly symptomatic. The trial is done mostly at one's home. You must be 21 or older.

Those enrolled will be asked to come to the Robert Wood Johnson Medical School on the Rutgers campus for a brief physical exam, and then given a combination of three drugs: nitazoxanide, ribavirin and hydroxychloroquine.

They will be given the drugs in pill form and instructed to take them over a period of just five days. Trial participants will be given equipment to test themselves at home via nasal swab several times, to see if the viral load has reduced over that five-day period. They will then return to the clinic at days 14 and 28 for a status check.

Hydroxychloroquine? Yes, the same drug much hyped by President Donald Trump and others, but yet did not prove effective in past clinical trials, such as this study done by U.S. Veteran's Affairs in April.

According to Dr. Carson, the key difference is that in this trial, hydroxy — as it's called for short — is being used in combination with other drugs.

"It was purported by some to be a wonder drug. And then it got tested in clinical trials and was shown not to be effective," said Dr. Carson, speaking of hydroxy.

"So people got concerned. But some of these drugs have been shown not to be effective when used alone. But multiple medicines work. It's all about coming up with a combination of drugs that block the sequential replication of the virus."

"When you add hydroxychloroquine with these other drugs, the combination is highly, highly synergistic and effective, increasing the efficacy up to eight times in some cases," he continued. "It increases the potency tremendously. It's really not just 1+1+1 = 3. You get a huge effect."

Synavir Corporation, a biomedical research company located in Colorado, has been testing a variety of combination of drugs against coronavirus since the outbreak first began. They are the ones who came up with the nitazoxanide/ribavirin/hydroxychloroquine combination in lab tests, and now partnered with Rutgers to test it on human subjects.

“To successfully treat life-threatening RNA viruses such as SARS-CoV-2, we believe that antiviral medicines must act on multiple, sequential points in the viral replication life cycle," said Greg Went, co-founder at Synavir.

The ultimate goals? Preventing New Jersey's hospital system from being overwhelmed with COVID patients, keeping patients off ventilators and also preventing the spread of a very contagious virus.

"We don't know if it's going to work," said Dr. Carson. "But we have good evidence that shows it should."

The researchers are seeking referrals from physicians of outpatients with a SARS-CoV-2 positive test within seven days. To be eligible, patients must have been diagnosed within the previous six days, preferably within the last two days. For more information, call 833-874-2281 (1-833-TRIACT1), email triact@rwjms.rutgers.edu or visit www.triact1.com.