Henry Ford Health System is first in the country to enroll a patient in the Human Epidemiology and Response to SARS-CoV-2 (HEROS) study, which aims to help determine the rate of SARS-CoV-2, the virus that causes COVID-19, among U.S. children and their family members, and what percentage of children infected with SARS-CoV-2 develop symptoms of the disease. The study will also examine whether rates of SARS-CoV-2 infection differ between children who have asthma or other allergic conditions and children who do not. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is sponsoring and funding the HEROS study.
Henry Ford is the only health system in Michigan participating in the HEROS study.
Henry Ford Health System has long running pediatric research cohorts comprising some of the most diverse populations in the country. We are committed to studying pediatric health not only clinically, but also from an epidemiological perspective. We are honored to be part of this important research initiative that will provide meaningful insight into how the novel coronavirus affects some of the youngest members of our communities."
Christine Cole Johnson, Ph.D., MPH, chair of the Department of Public Health Sciences at Henry Ford Health System
The HEROS study team is rapidly enrolling 6,000 people from 2,000 U.S. families already participating in NIH-funded pediatric research studies in 11 cities. The study team will prospectively follow these children and their families for six months to determine who gets infected with SARS-CoV-2, whether the virus is transmitted to other family members, and which family members with the virus develop COVID-19.
Leading the HEROS study is Tina V. Hartert, M.D., MPH. Dr. Hartert is director of the Center for Asthma and Environmental Sciences Research, vice president for translational research, the Lulu H. Owen Chair in Medicine and a professor of medicine at the Vanderbilt University School of Medicine in Nashville.
"We are still early in this pandemic and there is a lot that we still do not know about SARS-CoV-2 infection, including why children are fortunately less likely to become critically ill when infected," said Dr. Hartert. "The collective expertise and contributions of Dr. Johnson and her team at Henry Ford have been critical to launching this much needed population study that includes testing children and families over months, including for the presence of antibodies in the blood as a marker of previous infection. The HEROS study will fill important knowledge gaps that will help to inform public health interventions."
Preliminary evidence suggests that having an allergic condition paradoxically may reduce a person's susceptibility to SARS-CoV-2 infection and severe COVID-19 disease. An NIAID-funded study recently examined upper and lower airway cells for the expression of ACE2, the gene that codes for the receptor that the coronavirus uses to infect cells. ACE2 expression is necessary for a cell to make this receptor, but additional steps also are involved. In both children and adults, respiratory allergy, asthma and controlled allergen exposure were associated with significantly reduced ACE2 expression. The expression of ACE2 was lowest in people with high levels of both asthma and sensitivity to allergens.
The HEROS study will further clarify whether reduced ACE2 gene expression in airway cells of children with allergic diseases correlates with a lower rate of SARS-CoV-2 infection and COVID-19.
The study will be conducted completely remotely. Every two weeks, a caregiver in participating families will collect nasal swabs from the child who is the primary study participant and all other family members who are enrolled in the study, and will mail the samples to a laboratory for analysis. On the same day as the nasal swab, the caregiver will complete online questionnaires about each participant's current symptoms, social distancing practices, recent activities outside the home, and recent exposure to people who are sick.
In addition, if any member of the household develops symptoms of a viral illness, the caregiver will fill out another online questionnaire designed to determine the likelihood that the illness is COVID-19. If COVID-19 is likely, the caregiver will collect nasal swabs from all study participants and a stool sample from the symptomatic participant within 24 hours.
Laboratory analyses of nasal swabs will test for SARS-CoV-2 and assess gene expression in the collected airway-surface cells. Investigators hope that these gene expression studies will reveal patterns that correlate with higher or lower risk of infection, COVID-19 symptom development and SARS-CoV-2 transmission.
A caregiver also will collect a blood sample from each study participant two weeks, 18 weeks and 24 weeks after enrollment as well as three weeks after the family's first likely case of COVID-19, if there is one. The blood will be collected using a new, nearly painless device that extracts a small quantity of blood through the surface of the skin. The blood will be analyzed for antibodies to SARS-CoV-2 once an appropriate antibody test becomes available.