Samaritan COVID-19 Clinical Trial Shows Promise

What do diabetes and COVID-19 have in common?

Two things:

• Elevated blood sugar levels lead to diabetes, and some COVID-19 patients are experiencing elevated levels as well.
• A medication used to treat diabetes is showing promise for treating COVID-19.

Samaritan Health Services recently completed a limited clinical trial in which the blood sugar treatment medication pioglitazone was used to treat 10 patients hospitalized with COVID-19. Eight of those 10 patients recovered enough to go home without further assistance.

This trial began after Brian Delmonaco, MD, lead intensive care hospitalist at Good Samaritan Regional Medical Center, noticed a trend of elevated blood sugar levels among hospitalized COVID-19 patients.

“When the pandemic hit, I observed after several patients that all of them had elevated hemoglobin A1C levels,” Dr. Delmonaco said. “Many of these patients didn’t know they had diabetes.”

The hemoglobin A1C test determines the patient’s average blood sugar level over the prior three months. Normal is below 5.7% and the levels in COVID-19 patients were in the diabetes range of 6.5% or higher.

Dr. Delmonaco’s observation led him to ask Jarrod Brubaker, MBA, hospital pharmacy manager, if any diabetes medication had been tested for treatment potential on a coronavirus-related illness. Brubaker said that pioglitazone had been studied as a treatment for lung inflammation in patients with influenza type A. Lung inflammation is one of the symptoms of COVID-19 that can lead to a patient needing a ventilator.

Pioglitazone has also attracted interest around the world. Researchers from Asia as well as the University of California – San Francisco have done computer models of medications in this class, to find that these medications can possibly interrupt the novel coronavirus from interacting with human cells and duplicating itself once inside the human body.

“So, pioglitazone hypothetically works in several different ways to help patients with COVID-19,” Dr. Delmonaco said.

Dr. Delmonaco worked with Brubaker and Samaritan’s research team to develop an initial clinical trial called GOTCHA (GlitazOne Treatment for Coronavirus HypoxiA) to determine if pioglitazone would be safe for COVID-19 patients. The trial, approved by the Institutional Review Board (IRB), included 10 hospitalized patients across Samaritan’s service area who were moderately ill but not initially on a ventilator.

The trial ran from early May to late July, with eight of the 10 patients recovering to go home. One patient is still hospitalized and one patient died in the hospital.

“This is important because overall, 52% of COVID-19 patients in the ICU recover to go home,” Dr. Delmonaco said. “With this study, most of our patients were in the ICU, all needed supplemental oxygen, three needed a ventilator and our discharge rate was 80%. We’re also seeing signals in the data that it can lead to shorter hospitalization times when the patient is moderately ill – not on a ventilator.”

Dr. Delmonaco said this study is unique in that it consisted of using an approved medication for an already-approved use.

“It comes down to helping patients, and I’m thankful to these patients and their families for their consent to be enrolled in our study,” Dr. Delmonaco said.

He also credits all of Samaritan for this trial’s success, as patients throughout Benton, Lincoln and Linn counties were involved.

“We had to get consent from patients while they were in isolation,” Dr. Delmonaco said. “That presented some challenges for our research team and the nursing teams, but they overcame all of those challenges.”

Given these results, Dr. Delmonaco and the research team are now developing an expanded study called GOTCHA 2.0. Once approved by the IRB, the study will include more patients to see if these results continue.

“Our hypothesis is that pioglitazone is safe and helpful in several respects: It helps decrease the amount of oxygen therapy needed and the rate of ventilator use, and it decreases the rate of mortality or adverse events,” Dr. Delmonaco said. “We have a few university medical centers around the country that are interested in joining our study.”

Dr. Delmonaco gave a Samaritan Med Talk presentation, in partnership with Samaritan Foundations, on the GOTCHA trial on Thursday, Aug. 13. The talk, presented by GBC Construction, is on this page for viewing.

Learn more about research and clinical trials at Samaritan.