NEW BRUNSWICK, NJ - Rutgers is leading a clinical trial that aims to assess the combination of three drugs’ ability to treat people 21 or older who are infected with the virus that causes COVID-19.
The trial is testing to see the efficacy of nitazoxanide, ribavirin and hydroxychloroquine in treating SARS-CoV-2 patients who are asymptomatic or mildly symptomatic., the university announced Monday.
The trial is being conducted with Synavir Corporation, a global health company that works with academia, industry and government to develop combination treatments for new viral infections.
The trial — called Triple Combination Antiviral Coronavirus Therapy (TriACT) — seeks to determine whether treating people who test positive for coronavirus but who do not have symptoms or have mild symptoms with this combination will reduce the amount of virus and their chances of getting sick.
There are no proven treatments for COVID-19, but there is some evidence that medications used to treat other infections might also work against COVID-19, especially if they are used in combination, according to a statement released by the university.
According to the statement, this three-drug combination has been shown in experimental studies to be highly effective in suppressing viral replication. Participants will be given the drug combination or a placebo.
“Medications for outpatients with COVID-19 that shorten the duration of the illness, prevent the need for hospitalization and, perhaps most importantly, prevent spread of the disease to others are a critical need that are currently missing in therapeutics,” said principal investigator Jeffrey Carson, MD, a Provost at Rutgers Biomedical and Health Sciences and a Distinguished Professor of Medicine at Rutgers Robert Wood Johnson Medical School.
Hydroxychloroquine has been touted by President Donald Trump as a “game-changer” in its ability to treat patients with COVID-19. Until Trump took to Twitter starting in March to praise the drug, it had been primarily used to prevent malaria.
According to Rutgers, the trial will assess the rate of decline in viral load in 70 people over 10 days and compare the proportion of participants who are asymptomatic and symptomatic at 10 days versus the time of onset; the frequency of the development of fever and other symptoms of COVID-19 in those who were asymptomatic at enrollment; the progression in severity of COVID-19 symptoms, including hospitalization and length of stay, admission to an intensive care unit and the number of days in the unit, and death of any cause; the severity of disease in participants who develop symptoms of COVID-19; and the side effects of the therapy compared to a placebo.
It also seeks to determine whether the baseline viral load predicts response to therapy and new COVID-19 infection in household members.
The trial was designed to allow the study participants to largely participate safely from home. They will visit the clinic only three times. They will receive a TriACT Study Kit, which includes the study medicine, swabbing kits and all other materials needed to complete the investigation, within 10 days, and will return to the clinic at days 14 and 28 for a status check.
“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 Gregory T. Went, co-founder at Synavir. “We are pleased to collaborate with Dr. Carson’s team to investigate this approach to treatment of COVID-19 and potentially help improve outcomes for newly diagnosed patients.”
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 email@example.com or visit www.triact1.com.