A study to help determine the incidence rate of the coronavirus disease 2019 (COVID-19) in children and their family members has begun enrolling participants in the United States, according to the National Institutes of Health (NIH).1

As of April 27, researchers from JAMA Pediatrics recommended that future epidemiologic and clinical studies are needed to identify possible preventive and therapeutic strategies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pediatric patients.2

The Human Epidemiology and Response to SARS-CoV-2 (HEROS) study will help determine what percentage of children infected with SARS-CoV-2 develop symptoms of COVID-19. Additionally, the HEROS study will examine whether rates of SARS-CoV-2 infection differ between children who have asthma or other allergic conditions and children who do not, according to the study authors.1

The HEROS study team is planning to enroll 6000 people from 2000 US families already participating in NIH-funded pediatric research studies in 11 cities. Both healthy children and children with asthma or other allergic conditions will be able to participate.1

The study team will follow the children and their families for 6 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-19.1

A previous study recently examined upper and lower airway cells for the expression of ACE2, the gene that codes for the receptor that COVID-19 uses to infect cells. The expression of ACE2 was lowest in people with high levels of both asthma and those sensitive to allergens, according to the press release.1

The HEROS study will help 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-19.1

The study will be conducted remotely, with a caregiver in participating families collecting nasal swabs every 2 weeks from the child who is the primary study participants and all other family members who are enrolled. The samples will be mailed to a laboratory for analysis.1

In addition, the caregiver will complete questionnaires about each participant’s current symptoms, social distancing practices, recent activities outside the home, and recent exposure to people who are sick.1

If any member of the household develops symptoms of a viral illness during the study, 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.1

The laboratory analyses of nasal swabs will test for SARS-CoV-2 and assess gene expression in the collected airway-surface cells. The study team hopes that the gene expression studies will reveal patterns that correlate with higher or lower risk of infection, COVID-19 symptom development, and SARS-CoV-2 transmission.1

A blood sample will also be collected from each study participant every 2 weeks, 18 weeks, and 24 weeks after enrollment by the caregiver, as well as after the family’s first likely case of COVID-19, if applicable. A new device will be used to collect the blood, extracting a small quantity through the surface of the skin. The blood will then be analyzed for antibodies to SARS-CoV-2 once an appropriate antibody test becomes available.1

REFERENCE
  1. Study to determine incidence of novel coronavirus infection in US children begins. NIH. https://www.nih.gov/news-events/news-releases/study-determine-incidence-novel-coronavirus-infection-us-children-begins. Published May 4, 2020. Accessed May 4, 2020.
  2. Murphy, Jill. Lack of data on pediatric patients with SARS-CoV-2, further epidemiologic studies required. Contemporary Clinic. https://contemporaryclinic.pharmacytimes.com/news-views/lack-of-data-on-pediatric-patients-with-sars-cov-2-further-epidemiologic-studies-required. Published April 27, 2020. Accessed May 4, 2020.