U Health, Intermountain Healthcare Begins COVID-19 Clinical Trials

SALT LAKE CITY — Doctors from Intermountain Healthcare and University of Utah Health have started enrolling patients in two COVID-19 clinical trials to test the effectiveness and safety of controversial drugs that recently came up in a coronavirus briefing with the President.

Doctors leading the trials said they want to come up with answers about the two drugs quickly because lives are on the line. They want to find out if the two drugs can relieve severe symptoms from COVID-19, and maybe even slow down the spread.

“The goal of this trial is to make people better,“ said Dr. Samuel Brown, principal investigator of one of the studies, and a critical care researcher at Intermountain Healthcare.

When the two drugs — hydroxychloroquine and azithromycin — came up for discussion nationally, local researchers wanted to be able to provide answers.

“We heard the cry of distress from the community. We realize the urgency of the pandemic,” said Dr. Brown.

He said typically it would take a year to set up these trials, but these collaborative trials came together in two weeks.

“We want to test this in a pandemic. We want to know if it works. We want to get this out,” said Dr. Raj Srivastava, principal investigator of the outpatient trail, and assistant video president of research at Intermountain Healthcare. “These are our loved ones, just like your loved ones, so we’re going to work towards doing it.”

In two parallel trials, they want to find out how effective hydroxychloroquine and azithromycin are in reducing the severity of symptoms for those suffering from COVID-19, and whether the drugs can save lives. The other trial will explore whether the drugs can help people stay out of the hospital, help decrease viral shedding, and decrease transmission of the virus in a household.

The study was designed with three motivations:

“To find important answers. The other, was to provide access to these drugs. And, the third wants to do it in a safe way,” said Dr. Brandon Webb, principal investigator of the outpatient trial, and an infectious diseases physician at Intermountain Healthcare.

The two drugs are FDA-approved, used to treat malaria and pneumonia.

“These two medications are very, very commonly prescribed,” said Dr. Webb. “So we have a good understanding of their safety profile.”

Doctors said they plan to enroll nearly 2,300 patients who are COVID-19 positive, or suspected of being positive. Those people will be contacted shortly after their tests to find out if they are willing to enroll.

“We should have early results within the next 10 to 12 weeks, which is as Raj mentioned, as fast as possible,” said Dr. Rachel Hess, principal investigator of the outpatient trial, and co-director for the Center for Clinical and Translational Science at the University of Utah.

“So, that we can get real information in a safe way about what might help in COVID for patients who are COVID positive, or have a test pending and are very likely have COVID,” said Dr. Brown.

The researchers said there will not be a shortage of the drugs for those who are already taking those prescriptions during the trials.