When CHI Health facilities started seeing an influx of COVID-19 patients, Clinical Research immediately began looking for ways it could help Critical Care and Infections Disease teams amid the global pandemic.
The most prominent coronavirus-related project the Clinical Research team tackled was helping to support the Mayo Clinic’s expanded-access convalescent plasma program across CHI Health Critical Care physicians and the Clinical Research teams. As of Tuesday, May 19, a total of 85 patients had been registered across our acute-care facilities in Nebraska and North Dakota.
“When we initially saw COVID-19 patients in our hospitals, there wasn’t plasma product available because we didn’t have a lot of patients who were one month out from their recovery who could donate plasma,” said Kayleen Joyce, MS, CCRC, ACRP-PM, Research director for CHI Health. “One of the things that our research team in Omaha did was get senior leadership approval to reach out to recovered patients in our system to let them know about plasma donation.”
CHI Health Research staff in Nebraska (Grand Island, Lincoln, Kearney and Omaha) and North Dakota have all participated. The first COVID-19 convalescent plasma (CCP) donation was recovered in the system on April 16. As of May 8, LifeServe blood bank reported that more than 150 units had been collected.
“The ability for local patients to have quick access to CCP is a direct result of our strong medical partnership and (the CHI Health Clinical Research team’s) support in educating patients about the need and the importance of CCP donation,” said Dr. Alex Smith, LifeServe medical director.
LifeServe reported that the average time between order and receipt of a product is less than one day. While in some areas of the country, patients needing CCP have endured a seven-day wait time, the longest wait time at a CHI Health facility has been four days.
“There are a lot of hoops to jump through and there’s a lot of data that has to be documented for these patients, so the Research teams are supporting all of the critical care and infectious disease teams to help them,” Joyce said. “By pure numbers, it shows that we have the infrastructure to get this to our patients as much and as quickly as possible.”
Mary Gulzow, CHI Health Research division manager, is based at CHI Health St. Francis in Grand Island, but — prior to the COVID-19 outbreak — also regularly spent time with Research teams at CHI Health St. Elizabeth in Lincoln and CHI Health Good Samaritan in Kearney. Gulzow said the intensive paperwork requirements for patients receiving convalescent plasma fit the skillset of team members experienced with clinical trials.
“Knowing the work that it entails, we have pretty much donated our time to help our care teams as we knew what things looked like in ICU,” Gulzow said. “So when it started hitting, we were prepared. We started rearranging our staff to focus on COVID-19 because we knew that ICU nurses simply wouldn’t have time and the large number of forms and information that was needed is something that we’re used to.
“To us, it was a no-brainer that we were going to help. In many clinical trials, of course, you get financial assistance, but that wasn’t even in the discussion here. It was treatment and we were going to do it.”
Clinical Research is also supporting an expanded access program for novel immunotherapy agents for COVID-19 patients as well as participating in multi-institutional proning studies for patients on ventilators.
“We have been evaluating a number of COVID research opportunities that our providers have expressed interest and reviewing what is available on the national clinical trials websites,” Joyce said. “Since we are familiar with working with drug manufacturers, we were able to make initial contact and provide the necessary information so that CHI Health can be considered for these opportunities.
“Since we do not have any drugs approved for the treatment of COVID-19 at this time, there are additional regulatory hurdles to obtain emergency access. That’s where having our research infrastructure has been really essential so that we could support our critical care, infectious disease and pharmacy teams.”