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NCT04899245 · ClinicalTrials.gov registry record · NA

ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - COVID-19 Testing in School With Children and Staff

A NA study of COVID-19 and Children With Medical Complexity (CMC), sponsored by University of Wisconsin, Madison.

Completed
Registry status
NA
Development phase
112
Enrollment target
1
Study location

NCT04899245: Completed NA study of COVID-19 and Children With Medical Complexity (CMC), sponsored by University of Wisconsin, Madison.

NCT04899245 is a NA study of COVID-19 and Children With Medical Complexity (CMC) that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 112 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04899245, a NA study of COVID-19 and Children With Medical Complexity (CMC), has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
NA
Development phase
112 participants
Enrollment target
1
Study location

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.

Primary Outcome

Feasibility of school based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log. Two data limitations to note: * The enrollment rate was not stratified by caregiver and child number at the time of data collection. The data was collected at the level of the child. * The enrollment rate was not stratified by caregiver/child dyad and staff at the time of data collection. This is a limitation of our data. It is not possible to stratify this outcome and i

Interventions

  • DIAGNOSTIC_TEST BinaxNOW Rapid Antigen System

Study Locations (1)

Wisconsin

  • University of Wisconsin School of Medicine and Public Health - Madison

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2021-05-04
Est. Completion 2023-09-01
Phase NA
University of Wisconsin, Madison

1,039 total trials

What the finished NCT04899245 record still lists

NCT04899245 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).

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.

NCT04899245 reports a single indexed study location in Wisconsin.

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).

What interventions are being tested in trial NCT04899245?

The interventions under investigation include: BinaxNOW Rapid Antigen System (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04899245?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for COVID-19

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04899245's enrollment target sits among peer trials

112 191st of 298 higher than 106 of 298 other COVID-19 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04899245, the US trial registry maintained by the National Library of Medicine. NCT04899245 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.