Speeding discovery to find a treatment for COVID-19
Research teams shift focus nearly overnight to find solutions for COVID-19
Mark Brantly, MD ’79, and his team of 11 physicians, study coordinators and lab staff are working day and night at the UF College of Medicine to evaluate a treatment for the novel coronavirus that might block the deadly inflammatory response caused by the disease that curtails the lungs’ ability to function.
Mark Brantly, M.D. '79
Photo by Jesse S. Jones
nder normal circumstances, it can be a slow process, with thousands of other studies in line in what is a first-come, first-serve undertaking. In some cases, it can take a couple of months for approval.
Brantly’s approval came in five days.
The University of Florida Institutional Review Board, a committee consisting of 21 physicians, nurses, pharmacists, researchers and community members, approves all clinical trial protocols. This ensures federal, state and local rules and guidelines meant to protect patients’ rights and safety are followed.
“It was really done in record time,” said Brantly, a professor in the division of pulmonary, critical care and sleep medicine and the department of molecular genetics and microbiology. “That is the fastest I’ve seen it done in my career.”
This wasn’t happenstance. It’s by design. Amid the worst public health emergency in a lifetime, university leaders have taken steps to speed novel coronavirus research, recognizing the desperate need to provide answers and options to the communities they serve. Two key components of this effort: IRB retooling its approval process for coronavirus trials and the UF Clinical and Translational Science Institute, or CTSI, setting up a $2 million pilot research fund available to scientists with translational projects that can be rapidly mobilized.
Alek Aranyos, a biological scientist in Brantly's lab.
Photo by Jesse S. Jones
“UF Health researchers, like Dr. Brantly, are working tirelessly on innovative approaches to combating the novel coronavirus,” said David R. Nelson, MD, senior vice president for health affairs at UF and president of UF Health.
“We need to better understand the virus, search for new treatments and bring them from the bench to the bedside as rapidly and safely as possible,” he added. “To that end, we want to provide all the support we can to our scientists and staff to promote a rapid response to a health emergency unrivaled in modern times.”
The Institutional Review Board’s response to a pandemic
At any one time, hundreds of study protocols might be in the pipeline for IRB review. So, the board is streamlining the approval process by pushing coronavirus research to the front of the line, without sacrificing proper regulatory review or patient safety.
“It’s like when you go to Disney World,” said Peter Iafrate, PharmD, who has served as chair of the IRB for the UF Health academic health center since 1996. “If you stand in line, you can be there for two hours. If you have the right pass, you get right on. No matter how long you wait, the ride you get is the same. Once the IRB reviews the study, no shortcuts are taken.”
The full IRB is now meeting weekly via Zoom, rather than following its traditional biweekly schedule, Iafrate said. He is now spending up to 80% of his time reviewing COVID-19 projects.
CTSI launches $2 million COVID-19 awards program
The new CTSI funding effort is especially critical for these COVID-19 projects. The institute began accepting applications April 1 for the $2 million in funding, hoping for a rapid turnaround for grant approval.
In the world of science, grant proposals and funding awards are often many months, even years, in the making.
That obviously won’t do for COVID-19 treatments and vaccines.
Duane A. Mitchell, MD, PhD, the newly appointed CTSI director, assistant vice president for research and associate dean for translational science and clinical research, said CTSI funding can serve as a bridge until extramural funding becomes available.
Awards are capped at $100,000 each. The funding program is administered by CTSI with support from UF’s “Creating the Healthiest Generation” Moonshot initiative, UF Health and the UF College of Medicine.
“These pilot awards are designed to support initiatives that will have a near-term impact within the next six months on efforts that will either allow for the diagnosis, prevention or the treatment of COVID-19 disease, or the SARS-2 virus,” Mitchell said.
Tammy Flagg, assistant director of the Alpha-1 Research Program in Brantly's lab.
Photo by Jesse S. Jones
A potential treatment for COVID-19
Around the same time the first COVID-19 patient was admitted to UF Health Shands Hospital, Brantly, a pulmonologist, was approached to test the use of sarilumab to treat pneumonia in patients who tested positive for COVID-19. Until the outbreak of the novel coronavirus, the monoclonal antibody was used to treat rheumatoid arthritis, but Regeneron and Sanofi, the companies that jointly developed sarilumab, soon began investigating how the biologic could be used to treat a severe inflammatory condition called a cytokine storm, which was affecting around 10% of patients hospitalized with COVID-19.
After the five short days it took Brantly’s lab to gain approval to test the drug, UF Health patients suffering from COVID-19 could then be enrolled in the study, with the first on March 27. By the end of May, about 30% of UF Health’s COVID-19 patients had been enrolled. Brantly said he expects the adaptive study to continue, with small changes in dosing likely needed as it progresses.
Across the spectrum of research at UF, the all-hands-on-deck approach has brought forth innovation in record time. Existing teams of clinicians and researchers are adapting to the new normal and working to find the treatments and underlying processes that will benefit current and future COVID-19 patients in Gainesville and across the world.
