Michelle Mendoza, pharmacy technician, reconstitutes the remdesivir research drug under an intravenous hood at Brooke Army Medical Center, Fort Sam Houston, Texas, April 29, 2020. BAMC is participating in a COVID-19 treatment trial centering on the anti-viral drug, remdesivir. The National Institute of Allergy and Infectious Diseases (NIAID)-sponsored study has enrolled hundreds of people across the nation as it looks to determine if the antiviral drug is effective against COVID-19. (U.S. Army photo by Jason W. Edwards)
WASHINGTON—As the number of cases of COVID-19 seen in hospitals in many states decline, the VA and DoD have turned from active support of overwhelmed facilities to building deeper understanding of the disease and its impacts through new research studies and continued experience within their own ranks.
“We’re in a position to do things that no one else in the world can do to improve the health of our Veterans, the nation and the world,” said VA Secretary Robert Wilkie. “VA is bringing all of its expertise to bear during this crisis, and now we’re leading the way on research into pharmaceuticals and treatments that could improve the lives of thousands of patients.”
Among the more notable research projects, the VA has started a four-year study on the impact of COVID-19 on veterans. The Epidemiology, Immunology and Clinical Characteristics of COVID-19 (EPIC3) study will gather data as well as throat swabs and blood specimens to document effects of the virus.
“By analyzing data on COVID-19 risk factors, progression, outcomes and immunity, this VA research promises to significantly advance the fight against the disease,” Wilkie said. “The study will complement a similar effort by the Department of Defense.”
The VA’s Cooperative Studies Program will lead the effort, with support from epidemiology centers in Durham, NC; West Haven, CT; and Boston. The VA’s Seattle Epidemiologic Research and Information Center will coordinate the study and provide overall administration for all study sites.
“The aim of the study is to gather longitudinal data on the epidemiology, virology, immunology, and clinical characteristics of SARS-CoV-2 infections and the COVID-19 disease to answer key research questions about their natural history and clinical outcomes, and to better anticipate and manage pandemics in the future for Veterans Health Administration users and the general population,” according to the VA.
Volunteers for the study include hundreds of veterans who have been infected with the virus as well as those that have recovered and who are elevated risk but were not infected who are inpatients, outpatients, or live in the VA’s long-term Community Living Centers.
The DoD study will have a similar focus on active duty servicemembers.
Clinical Trials
The VA is also participating in a major, multisite trial of the promising drug remdesivir. Three VA sites—Palo Alto, CA; Denver, CO. and New Orleans, LA—have joined the study so far. Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), the trial required the VA to on a commercial institutional review board for the first time in its history.
Now that the VA can use commercial IRBs, it is positioned to be a “much more viable research partner for industry,” said Molly Klote, MD, director of the Office of Research Policy, Protections, and Education, part of VA’s Office of Research and Development.
“VA research is embedded in the largest integrated health care system in the country,” said Rachel Ramoni, MD, VA’s chief research and development officer.
No other healthcare system in the U.S. offers the scale of the VA, along with an integrated electronic health record and centralized database that simplifies research.
Ramoni’s group has been working closely with VA experts in virology, infectious disease, and epidemiology to evaluate new ideas and proposals related to COVID-19, including those for promising drugs like remdesivir and potential vaccines.
The office has aggressively pursued involvement in clinical trials for veterans and reworked processes to reduce the time to stand up a trial within the VA.
“Together, VA and industry can rapidly generate desperately needed knowledge for the prevention and treatment of COVID-19,” Ramoni said.
The VA has partnered with the Mayo Clinic for another study, this one evaluating whether patients with active COVID-19 symptoms can benefit from blood transfusions from those who have recovered. More than 60 VAMCs and clinics have signed up for the plasma study.
The Atlanta VA is participating in a trial of sarilumab, a drug used to treat rheumatoid arthritis, to see whether it might help patients infected with the novel coronavirus.
Earlier in the pandemic, a controversial study of hydroxychloroquine at the VA showed that it increased mortality rates in coronavirus patients. (See related article, pp. xx.)
Viral Spread
Using its High Performance Computing Modernization Program (HPCMP) headquartered in Vicksburg, MS, the DoD tackled the movement of air and viral-laden droplets inside the cargo hold of a C-17 aircraft to help Air Force medical evacuation crews understand and mitigate their risk during transport.
The same systems tackled the complex problem of viral spread on the USS Theodore Roosevelt and amongst its crew as it entered quarantine or isolation on Guam in response to the largest outbreak seen among active duty forces to date. In that situation, cases burgeoned from three to more than 1150 members of the aircraft carrier’s crew, and one sailor died.
Hundreds of sailors who initially tested negative and had no symptoms tested positive when screened to return to the ship. Even after those sailors were quarantined and cleared by being symptom-free and having two negative tests for the virus separated by 24 to 48 hours, 14 sailors tested positive again after they boarded the ship. They reentered quarantine.
The Navy was working closely with the U.S. Centers for Disease Control and Prevention.
The supercomputers may be tasked with another, similar challenge, determining how the novel coronavirus spread among 640 soldier trainees at Fort Benning, GA. All the trainees were tested for SARS-CoV-2 on arrival. The four who tested positive at that time were isolated for 14 days and recovered. A week later, another trainee began displaying symptoms and tested positive.
In response, all trainees were retested and 142 turned up positive. All positive cases have been isolated, but the experience of extensive spread among largely asymptomatic cohorts in two very different settings calls into question the DoD’s process for limiting the impact of COVID-19 on training and mission readiness. With its ability to process millions of options in a matter of weeks, HPCMP may reveal a better way to control the virus on ships and in training centers.
