2 Utah Clinical Trials Will Study Potential COVID-19 Treatment Drugs With 2,300 Patients

Researchers hope to recruit over 2,000 people for two Utah clinical trials involving two drugs that might be effective in treating COVID-19, the disease caused by the novel coronavirus, health officials announced Wednesday.

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Intermountain Healthcare and University of Utah Health announced the launch of the trials, which will study hydroxychloroquine and azithromycin. The researchers are aiming to involve 2,300 patients in the trials, according to a news release from Intermountain.

Some evidence suggests the drugs might have a moderate effect on COVID-19 symptoms and could prevent hospitalizations. Researchers at Intermountain Healthcare and the University of Utah worked day and night to launch the trials within two weeks. Typically, launching such a trial might take months or even years.

“We want to test this in a pandemic, we want to know if it works,” Dr. Raj Srivastava, an investigator for the Intermountain Healthcare trial, said Wednesday.

Hydroxychloroquine, also known as HCQ, is an anti-malaria treatment drug thought to be potentially useful to treat COVID-19. Azithromycin is an antibiotic commonly used to treat bacterial infections.

The clinical trials will aim to assess the safety of the drugs, as well as their effectiveness in reducing the severity and mortality of COVID-19.

Researchers are aiming to enroll at least 10 people per day for two months in the studies, said Dr. Rachel Hess, co-director for the Center for Clinical and Translational Science at the University of Utah and an investigator for the trials.

If they’re able to attain that level of participation, some early results from the studies could be available in 10-12 weeks, Hess added.

People age 45 and older who have tested positive for the disease are eligible for the trials. Researchers are focusing on that age group because younger people are thought to be less at risk for the disease, according to Dr. Brandon Webb, an infectious diseases doctor with Intermountain Healthcare.

People who may be eligible for one of the studies will be contacted by medical professionals, and they will be contacted after they have been notified of their positive COVID-19 result, according to Srivastava. All the clinical work will be done to make sure that COVID-19 patients get the care that they need before they are enrolled in a study.

One trial will be conducted with inpatients who are hospitalized with COVID-19. That portion of the study will include 300 people. The other portion will be conducted with about 2,000 outpatients.

Also critical during the studies will be keeping people who are taking the drugs safe. Neither medication is a “miracle drug” that will cure COVID-19 with no downsides, said Dr. Samuel Brown, a critical care researcher with Intermountain Healthcare.

“The goal of this trial is to make people better,” Brown said.

Dosages of the drugs will be administered within the Food and Drug Administration guidelines set forth for each medication, he added.

Hess added that health groups national and worldwide are looking at Utah’s public-private collaboration with the studies as extraordinary. The trials will hopefully be able to provide critical information not only to authorities here in Utah but also to health officials throughout the nation and world, she said.

“It’s really being looked at nationally as bringing answers to the questions being asked every day,” Hess said.

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