The way Cleary Waldren sees it, St. Luke’s has two options when it comes to the coronavirus: Sit on the sidelines and wait for other health systems to tackle the issue or help find solutions.
Waldren is pleased that St. Luke’s is going the latter route.
“Our research efforts need to align with St. Luke’s mission to care for those in the communities we serve,” said Waldren, St. Luke’s clinical research manager. “That can be complicated when we are up against something relatively new like COVID-19.
“To provide the best care possible means partnering with leading medical and scientific institutions to develop our knowledge base and bring leading treatments to Idaho. I think this is how research helps us provide the best possible care for our patients.”
St. Luke’s recently concluded its participation in a global study, known as EMPACTA, to evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in hospitalized patients with COVID-19. TCZ is used to treat rheumatoid arthritis, among other things; a serious effect of COVID-19 is the buildup of fluid in the lungs, and the drug is being studied to see if it can slow or lessen the accumulation of fluid in COVID patients’ lungs.
“They had about 88 sites that they selected by the end of the study, looking for 375 patients globally,” Waldren said. “When you do the math, they were looking for about four patients per site, on average. Due to the unfortunate rise in cases within our region, we enrolled eight.
“So, in the setting of this global and very important clinical trial, Idaho really contributed significantly to the enrollment and the science.”
Results of the study have been passed along to the study’s sponsor, Genentech, which will sift through the data and seek to publish in a peer-reviewed journal.
“I would say we’re still four months out before we completely understand the results of EMPACTA,” Waldren said.
Dr. Karen Miller, a St. Luke’s pulmonologist, directed the research project as principal investigator.
“I’ve been doing clinical research for the past eight years,” Dr. Miller said. “The studies were always cystic fibrosis studies, until EMPACTA. It was our first inpatient study, and our first infusion study.
“I was impressed, almost beyond belief, by what we achieved during the EMPACTA study, in terms of training people, bringing people on board, enrolling patients and dealing with different issues from top to bottom.”
Teams that supported the EMPACTA research effort included:
Trials such as this one lead to advances in understanding of disease and improvements in care, Waldren noted. That was not lost on participating patients.
“The study was extremely inspirational,” Dr. Miller said. “There’s nothing like talking to a patient who is in the depths of despair because they have this terrifying virus, and then being able to offer them participation in an important trial.
“I’ve seen patients be overwhelmed with gratitude to be able to be part of this research.”
With the EMPACTA study closed, St. Luke’s will now turn its focus to another study. Called REMDACTA, this research will evaluate the efficacy and safety of remdesivir plus tocilizumab, compared with remdesivir plus a placebo, in hospitalized patients with COVID-19 pneumonia. Remdesivir is a broad-spectrum antiviral medication believed to have an anti-viral effect on COVID-19. The drug is being studied by itself and in combination with TCZ for those suffering from severe COVID-19 pneumonia.
“The REMDACTA study involves about 33 sites around the world, and we are one of them,” Waldren said. “I think one of the things that went into picking us as a site is that we have a better research infrastructure here in Idaho than people would guess.”
Waldren is confident that the health system can be a significant contributor in REMDACTA and other important clinical studies going forward.
“These studies provide us with access to leading medical scientists and expertise related to COVID-19 treatment,” he said.
“Providing our patients with an opportunity to help the world understand this virus and how to treat it is providing them an opportunity to join the fight and make a big difference.”
Chart provided by PMG Research's white paper Clinical research participation as a care option.
Chris Langrill is a writer and copy editor for the St. Luke’s Communications and Marketing department.