A Norfolk native is spearheading the first clinical trial in the nation for the new coronavirus.
LuAnn (Bohm) Larson is the director of clinical research operations at the University of Nebraska Medical Center (UNMC), which announced Tuesday the launch of the first U.S. clinical trial to evaluate an experimental treatment for coronavirus disease 2019 (COVID-19), according to a National Institutes of Health (NIH) media release.
Larson, who was born in Norfolk and attended Norfolk High School, has been working at UNMC since 1988, she said. Larson’s mother, JoAnn Cech, still lives in Norfolk.
She graduated from the Methodist College of Nursing before working at the UNMC adult intensive care unit. She eventually became the manager of the pulmonary research department and then was hired to start the Clinical Research Center in 1996.
“I have always loved my work at UNMC because I am always learning new things,” Larson said. “I now have a whole team with each having their own role to start and conduct studies. We are here to help all investigators on campus to do research.”
Larson helps manage a team of about 40 employees to get research studies started on campus and to help conduct clinical trials, she said. The research center coordinates about 60 studies at a time, but the university is now managing a lot more.
The research center is conducting a randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral drug called remdesivir in hospitalized adults diagnosed with COVID-19. It is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH.
“Everyone's very excited about it,” Larson said. “There are multiple centers across the country that want to be a part of the study.”
Patient treatment in Omaha
The first trial participant is an American who was brought to the UNMC campus after being evacuated from the Diamond Princess cruise ship off the coast of Japan, according to an NIH media release. The person volunteered to participate.
The participant is among 15 people from the ship who are under quarantine at UNMC — 13 in the National Quarantine Unit and two in the separate Nebraska Biocontainment Unit, according to an official UNMC statement. Thirteen of the evacuees have tested positive for COVID-19 while two continue to be negative.
The first 13 people quarantined arrived in Omaha on Feb. 17. The 14th landed Monday after being transferred from a Texas Air Force base, and a 15th arrived Tuesday night from California. Clinical trial participants will be cared for in the biocontainment unit.
Larson is used to studying international viral outbreaks, she said. She was also part of the UNMC team that tackled the Ebola virus disease in 2014.
She said the process and protocol for treating both outbreaks at UNMC have been similar.
“Remdesivir has been used previously in the Ebola outbreak and again with other coronaviruses like MERS (Middle East respiratory syndrome) and I think with SARS (Severe acute respiratory syndrome) as well,” Larson said. “It did not perform as well in the Ebola virus but did quite well with the other respiratory syndromes.”
When evaluating which clinical trial drug would be best, health officials decided on remdesivir because of its previous efficacy, Larson said. There are other drug choices that may come into play if the research center decides the drug isn’t working well with COVID-19.
Each clinical trial Larson manages has to be reviewed by the Institutional Review Board (IRB), which is responsible for protecting the rights and welfare of study participants and evaluates risks with benefits, weighing if a study should be done at UNMC.
It can take awhile for the IRB to either approve or deny a clinical study, but the board reviewed the COVID-19 trial the same day it was submitted through a rapid response protocol.
NIAID is planning to offer the study to 50 centers around the world, Larson said. Clinical trials of remdesivir also are ongoing in China.
“If you don't do a research study and look at the data, you don't know what's working,” Larson said. “That's why we do a controlled study to scientifically determine the effectiveness and safety of new treatments.”
Larson usually works almost 12-hour shifts, but her days have grown longer since the coronavirus outbreak, which was first detected in December in Wuhan, China. Even with tiring hours, Larson said she loves to come to work at the research center.
“I couldn't be more pleased; this team successfully treated patients with Ebola in 2014 and are stepping up to the plate again to care for our citizens because we care,” she said.
The federal Centers for Disease Control and Prevention said on its website Tuesday that more cases of COVID-19 are likely to be identified in the near future, including more U.S. cases.
“It's probably likely it's not going to stay contained,” Larson said. “We need to start thinking what we're going to do and how we're going to handle it.”
Larson recommends that people start making habits of washing their hands before touching their mouths, eyes or face. People also should practice social distancing, which is staying at least 6 feet apart from another person.
UNMC has been using extreme safety precautions during the COVID-19 outbreak, Larson said. Each employee involved in the clinical trial will wear special protective gear and there are standard operating procedures for taking it on and off.
When it comes to feedback from family and friends about Larson’s work, they say they’re very proud, she said.
“We went through Ebola together, and that was initially scary,” she said. “But now they're kind of used to it.”