Children’s Colorado was part of NIAID coalition to design and implement HEROS study.
HEROS used sample self-collection for detection of viral RNA in nasal secretions to gauge infection rate.
HEROS demonstrated an approach for rapid execution of future clinical research.
Background: HEROS remote study of SARS-CoV-2 in children
This prospective, six-month study of SARS-CoV-2 within households with children began in March 2020 during the national lockdown. The study remotely enrolled participants throughout the United States using direct-to-participant methods, which included self-collection of samples.
A consortium assembled by the National Institute of Allergy and Infectious Diseases (NIAID) to design and implement The Human Epidemiology and Response to SARS-CoV-2 (HEROS) study to address gaps in understanding of:
- Rate children were infected and potential role in silent transmission
- Role of asthma and other allergic diseases, including eosinophilic gastrointestinal diseases, as risk factor for severe infection
- Whether infection and transmission were longitudinally associated with host natal transcriptome
Methods: HEROS SARS-CoV-2 surveys and sample collection
The study included children currently or previously enrolled in National Institute of Health (NIH)-funded asthma and allergic disease-focused studies and members of their household.
Participants received weekly questionnaires and biweekly nasal collections over the May 2020 to February 2021 study period, which was prior to vaccine availability.
Primary objective: rate of SARS-CoV-2 infection by detection of viral RNA in nasal secretions.
Participants and enrollment
Population-based and disease-specific cohorts were recruited for study, including principal participants under 21 years old and household contacts from 20 NIH-funded cohorts in 12 U.S. cities and 13 individual sites.
There were 66 participants from Children’s Colorado’s NIAID-sponsored gastrointestinal, asthma and allergic diseases research centers, as one of the coordinating study sites. In addition, Children’s Colorado patients enrolled in the Consortium for Gastrointestinal Eosinophilic Disease Research (CEGIR) natural history study, “Outcomes of Eosinophilic GI ReseArch (OMEGA),” were part of the focus of this study. Furuta serves as administrative Principal Investigator of CEGIR.
A total of 1,913 households enrolled in the study:
- 2,950 children
- 2,648 adults
Data from all participants, even those who did not complete the full study were included in the analysis.
- Weekly surveys for symptoms and illness
- Every other week surveys for household exposure information
- Surveys conducted via smart phone, online, or telephone calls from local study staff
- Biospecimens collected from participants via mailed kit, including nasal swab, capillary blood, and stool
SARS-CoV-2 infection was defined through PCR testing on nasal and stool swabs and the average relative viral load value for each sample.
Completion of HEROS SARS-CoV-2 study
Of the 1,913 total households enrolled:
- 1,020 completed study
- 90% weekly survey response rate
- 92% biweekly survey response rate
- 893 withdrew from study
- 80% did not complete surveys, sample collection after enrollment
- 18% elected to withdraw
- more black or African American participants withdrew compared to white participants
Of the 5,598 individual participants enrolled:
- 3,081 completed study
- 2,517 withdrew from study
Of the 3,030 eligible participants over age 2:
- 85% stool samples collected
- 82% baseline capillary blood samples collected
- 66% end-of-study capillary blood samples collected
Discussion and conclusion: HEROS as future research approach
The most important obstacle during the HEROS study was the dropout rate. Study authors noted possible contributing factors, including:
- Significant delays in distributing biospecimen kits due to lock-down associated difficulties
- Relatively complicated instructions in sample kits
- Inconsistency with clinical site staff contacting, assisting participants
- Overall demands of the study amidst unprecedented health crises
This study was successfully implemented across 12 U.S. cities using biospecimen collections without in-person research visits. The study offers an approach for rapid execution of future clinical research.