The Uniformed Services University of the Health Sciences’ Infectious Disease Clinical Research Program is leading a multi-year study to identify risk factors for COVID-19 in the military population, understand the symptoms and disease course, and investigate clinical outcomes.

Epidemiology, Immunology, and Clinical Characteristics of Emerging Infectious Diseases with Pandemic Potential – or EPICC – study hopes to inform the Military Health System on ways to improve the patient care and treatment, infection, and disease prevention of those with COVID-19. USU is working in partnership with a network of military commands, treatment facilities, and laboratories across the country for EPICC.

Findings from the study “will support further understanding of the impact of SARS-COV-2 infection on active-duty readiness, acute and chronic clinical outcomes, the effectiveness of new treatments and vaccines, and address questions related to the emergence of new variants and their clinical impact,” said Dr. Brian Agan, deputy science director of IDCRP and principal investigator of the study.

The study is also evaluating how long the immune response to the COVID-19 vaccines lasts, breakthrough infections – which happen when a vaccinated individual becomes sick from the same illness the vaccination is designed to prevent – and how they behave over time, and estimating vaccine effectiveness, said Agan, who is also an employee of the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.

Department of Defense service members and MHS beneficiaries of any age with COVID-19-like illness who are admitted to the hospital or treated as outpatients at an EPICC site can join. Likewise, those 18 years or older who have been tested for COVID-19, whether they tested positive or negative, can participate in the online portion of the study, which includes self-collected blood specimens for selected participants.

The protocol was recently updated to also enroll COVID-19 vaccine recipients and will initiate recruitment upon approval, said Navy Capt. (Dr.) Timothy Burgess, program director of IDCRP, who oversees the study. Eligible beneficiaries who are interested in participating in EPICC can submit an online screening form to join.

“In addition, asymptomatic individuals with a high risk of exposure are also eligible for enrollment in EPICC, which includes health care workers and close contacts of cases,” said Burgess. “Particularly, health care workers who have received a COVID-19 vaccination will be an important population for studies to examine vaccine effectiveness and outcomes.”

Data from inpatient, outpatient, and online participants, including their clinical characteristics, comorbidities, the clinical course of their illness, treatment, immunology, and outcomes, is being collected for the study.

“Questionnaires are provided to enrollees to collect information on demographics, symptoms at initial presentation and chronic or persisting symptoms during follow-up, exposure history, and lifestyle factors,” said Burgess. “Clinical and research specimens collected from enrollees are examined using molecular, serological, and other immune assays in collaboration USU and non-USU partner laboratories.”

Initiated in March 2020, EPICC is expected to continue enrolling participants at least through March 2022, or for as long as needed to fill in the knowledge gaps related to this disease, explained Agan.

“Once enrolled, participants are actively followed for one year to fully capture specimens and data including chronic outcomes and sequelae and will be followed for up to four additional years through electronic medical record review,” Agan said.

EPICC is being conducted at 10 military medical treatment facilities throughout the United States:

• Brooke Army Medical Center in Fort Sam Houston, Texas
• Carl R. Darnall Army Medical Center in Fort Hood, Texas
• Fort Belvoir Community Hospital in Fort Belvoir, Virginia
• Joint Base Lewis-McChord, Washington
• Naval Medical Center Portsmouth in Portsmouth, Virginia
• Naval Medical Center San Diego in San Diego, California
• Tripler Army Medical Center in Honolulu, Hawaii
• William Beaumont Army Medical Center in El Paso, Texas
• Womack Army Medical Center in Fort Bragg, North Carolina
• Walter Reed National Military Medical Center in Bethesda, Maryland