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ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - COVID-19 Testing in School With Children and Staff
NCT04899245 · View on ClinicalTrials.gov ↗
Study Summary
The Coronavirus Disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, is a worldwide pandemic that has resulted in large-scale quarantines in cities, states, and countries throughout the world. SARS-CoV-2 is a respiratory virus that is most commonly spread via contact with infective respiratory droplets and aerosols produced by coughing, sneezing, talking, and singing. Children with medical complexity (CMC), i.e., children with multiple severe chronic conditions, high resource use, severe functional limitations, and substantial family-identified service needs, are a medically vulnerable population for the development of severe COVID-19. Deciding to send CMC to school poses a major dilemma to families wanting to minimize severe COVID-19 risk. School personnel also face risks when CMC attend school. Despite these challenges, achieving in-person school attendance is critical for CMC. Compared to non-CMC, academic and social development for most CMC hinges on being at school. Severe intellectual and developmental disability impairs one's ability to engage with online platforms. Health-promoting services delivered at school, e.g., physical, occupational, and speech therapy, are likely less effective when delivered virtually. Parents of CMC, already disproportionately unemployed due to their child's care needs, experience added employment strain when their child is out of school. The study objective is to increase the safe return to school for CMC by 1) evaluating the feasibility of school-based COVID-19 testing strategies and 2) identifying parent and staff perceptions of testing and school attendance. A related study (ReSET Aim 1a, NCT04895085) will evaluate the same factors in home-based testing strategies in CMC exclusively.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST BinaxNOW Rapid Antigen System
Study Locations (1)
Wisconsin
- University of Wisconsin School of Medicine and Public Health — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2021-05-04 |
| Est. Completion | 2023-09-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04899245
The ClinicalTrials.gov registry entry for NCT04899245 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 943 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention — of which BinaxNOW Rapid Antigen System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04899245 reports 1 study location spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04899245 about?
NCT04899245 is a clinical study titled "ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - COVID-19 Testing in School With Children and Staff". The Coronavirus Disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, is a worldwide pandemic that has resulted in large-scale quarantines in cities, states, and countries throughout the world. SARS-CoV-2 is a respiratory virus that is most commonly spread via contact with infective respiratory d...
What is the current status of trial NCT04899245?
This trial is currently completed. It is a NA study. The enrollment target is 112 participants. The study started on 2021-05-04. Estimated completion is 2023-09-01.
What conditions does trial NCT04899245 study?
This clinical trial studies the following conditions: COVID-19, Children With Medical Complexity (CMC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04899245?
The interventions under investigation include: BinaxNOW Rapid Antigen System (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04899245?
This trial is sponsored by University of Wisconsin, Madison, which has 943 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04899245 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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