Advocate Aurora Health contributed to clinical trial findings recently published in the journal Critical Care, which show that a new investigational drug safely and effectively reduced length of hospital stay and mortality in people with COVID-19 pneumonia.
The publication was coauthored by pulmonologist Raul Mendoza-Ayala, MD, the study’s principal investigator for Advocate Aurora Research Institute and Aurora BayCare Medical Center in Green Bay, Wisconsin. Advocate Aurora researchers enrolled 19 participants in the study at Aurora BayCare.
“The promising results from this clinical trial come as COVID-19 cases are again on the rise,” Dr. Mendoza-Ayala said. “Despite the successes of the vaccines and a few other therapeutics against COVID-19, there is still clearly much to learn about the virus and more advancements in treatment to be made, especially for the sickest patients, such as the people with respiratory failure who participated in this study.”
Researchers found that the study drug, Auxora, reduced a participant’s time to recovery from 10 days to seven days overall. What’s more, when the researchers compared groups of study participants who were receiving similar levels of supplemental oxygen, researchers found that treatment with Auxora nearly cut in half the participants’ time to recovery – from 17 days to nine days.
Also, the clinical trial demonstrated that treatment with Auxora significantly reduced a participant’s chance of death. When the rate of death was compared between study groups, participants who received Auxora had a lower mortality rate when measured after 30 days (7.7% vs. 17.6%) and after 60 days (13.8% vs. 20.6%).
The study, known as CARDEA, was the first blinded, randomized, controlled clinical trial to evaluate a type of drug called a calcium release-activated calcium (CRAC) channel inhibitor in critically ill participants.
“Prior studies have shown that CRAC channel inhibitors can block the release of inflammation-causing proteins and prevent cellular damage in organs, such as the lungs,” Dr. Mendoza-Ayala said.
The study sponsor, CalciMedica Inc., manufacturer of Auxora, ultimately halted enrollment in the clinical trial due to conditions at the time, which included declining numbers of both COVID-19 cases and hospitalizations and the quickly changing standard of care for COVID-19 patients.
But after analyzing the data, the significant findings led researchers to recommend that future phase 3 clinical trials continue to study the effects of Auxora, particularly in combination with other COVID-19 treatments.
“As we have come to realize, this virus is constantly changing and does not appear to be going away anytime soon, which makes the search for new COVID-19 treatments an important part of Advocate Aurora Research Institute’s work,” said Nina Garlie, PhD, vice president of clinical trials research for the Research Institute.
To learn more about Advocate Aurora’s research, visit aurora.org/research.