NCT04895085 is a NA clinical trial of BinaxNOW Rapid Antigen System in COVID-19, sponsored by University of Wisconsin, Madison.

Who is sponsoring NCT04895085?

NCT04895085 is sponsored by University of Wisconsin, Madison.

What drugs are being tested in NCT04895085?

Interventions in NCT04895085: BinaxNOW Rapid Antigen System.

What condition does NCT04895085 study?

NCT04895085 studies COVID-19, Children With Medical Complexity (CMC).

Is NCT04895085 still recruiting?

NCT04895085 is currently completed. Last updated 7 June 2024.

Are results published for NCT04895085?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-07 · How we verify

NCT04895085

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort COVID-19 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance

Completed NA Results posted Last updated 7 June 2024

What this trial tests

NA trial testing BinaxNOW Rapid Antigen System in COVID-19 in 51 participants. Completed in 15 September 2023.

Timeline

27 April 2021

Primary endpoint
15 June 2023

15 September 2023

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	51
Start date	27 April 2021
Primary completion	15 June 2023
Estimated completion	15 September 2023
Sites	1 location across United States

Drugs / interventions tested

BinaxNOW Rapid Antigen System

Conditions studied

COVID-19 — all drugs for COVID-19 →
Children With Medical Complexity (CMC) — all drugs for Children With Medical Complexity (CMC) →

Sponsor

University of Wisconsin, Madison

Who can join

18 and older, any sex, with COVID-19 or Children With Medical Complexity (CMC). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants Approached Primary · Study duration (up to 21 months)

Feasibility of home based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log.

Number approached, consented

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	51

Number approached, not consented

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	33

Change in Mean Number of Weekly in Home COVID-19 Tests Primary · Every week up to 21 months

Feasibility of home based COVID-19 testing will be evaluated by the mean number of weekly in home COVID-19 tests run by parents/caregivers. Data will be collected by survey.

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	1.8	± 0.3

Change in COVID Test Rate at Home: Number of Total Tests Completed as Compared to Number of Tests Expected Primary · Study duration (up to 21 months)

Data will be collected by survey. * Tests expected: Various scenarios factor into the tests expected value. Caregivers were expected to test their child twice a week every week for the first three months. After that time, caregivers could opt-in to surveillance testing (expected testing twice a week every week) or proceed with symptomatic-only testing (no "expected" tests for caregivers). Additionally, caregivers were not expected to test for 90 days after their child tested positive. * Tests completed: Caregivers were allowed to test more often than twice a week if appropriate (e.g., exposur

Number of tests completed

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	3254

Number of tests expected

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	2572

Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed Primary · Study duration (up to 21 months)

Data will be collected from parents via survey.

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	729

Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests Performed Primary · Study duration (up to 21 months)

Data will be collected from parents via survey.

Number of positive COVID-19 tests

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	39

Total number of tests performed

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	3254

Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 Testing Primary · Study duration (up to 21 months)

Data will be collected from parents via survey.

Number of negative confirmatory PCR tests

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	1

Total COVID-19 PCR tests

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	109

Surveillance Opt in: Number of Participants Opting Into Surveillance Compared to Total Number of Enrolled Participants Primary · At month 3

Data will be collected from parents via survey. \- Caregivers were expected to test their child twice a week every week for the first three months. After that time, caregivers could opt-in to surveillance testing (expected testing twice a week every week) or proceed with symptomatic-only testing (no "expected" tests for caregivers).

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	32
Caregiver of Children With Medical Complexity (CMC)	19

Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School Primary · baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

"How many of the people who interact with your child at school have been fully vaccinated?" Response options: "None", "A few", "Some" "Most", "All", "Don't Know" Dichotomized into: ("Most" or "All") vs. ("None", "A few", "Some", "Don't Know)

Baseline

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	12
Caregiver of Children With Medical Complexity (CMC)	39

3-month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	9
Caregiver of Children With Medical Complexity (CMC)	39

6-month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	12
Caregiver of Children With Medical Complexity (CMC)	34

9-month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	10
Caregiver of Children With Medical Complexity (CMC)	35

15-month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	16
Caregiver of Children With Medical Complexity (CMC)	23

18-month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	15
Caregiver of Children With Medical Complexity (CMC)	24

21-month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	15
Caregiver of Children With Medical Complexity (CMC)	26

24-month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	17
Caregiver of Children With Medical Complexity (CMC)	27

Change in Susceptibility: School Takes Precautions Primary · baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

The following question from the Participant's perceived susceptibility survey will be answered dichotomously and presented qualitatively: * How comfortable are you with...the ability of your child's school to take all precautions to stop the spread of COVID-19? * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

Baseline

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	24
Caregiver of Children With Medical Complexity (CMC)	27

3 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	17
Caregiver of Children With Medical Complexity (CMC)	31

6 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	20
Caregiver of Children With Medical Complexity (CMC)	26

9-12 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	24
Caregiver of Children With Medical Complexity (CMC)	21

15 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	16
Caregiver of Children With Medical Complexity (CMC)	23

18 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	16
Caregiver of Children With Medical Complexity (CMC)	21

21 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	13
Caregiver of Children With Medical Complexity (CMC)	30

24 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	21
Caregiver of Children With Medical Complexity (CMC)	24

Change in Susceptibility: Likely to Get COVID-19 Primary · baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Following questions from the Participant's perceived susceptibility survey will be answered dichotomously (agree or disagree) and presented qualitatively. * In your opinion, how likely is your child to get sick with COVID-19 by attending school in-person? * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

Baseline

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	22
Caregiver of Children With Medical Complexity (CMC)	29

3 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	18
Caregiver of Children With Medical Complexity (CMC)	30

6 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	21
Caregiver of Children With Medical Complexity (CMC)	24

9 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	16
Caregiver of Children With Medical Complexity (CMC)	28

15 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	19
Caregiver of Children With Medical Complexity (CMC)	20

18 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	23
Caregiver of Children With Medical Complexity (CMC)	16

21 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	23
Caregiver of Children With Medical Complexity (CMC)	19

24 months

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	25
Caregiver of Children With Medical Complexity (CMC)	20

Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected Primary · 15 month, 18 month, 21 month, 24 month

Parent survey perceived severity construct variables will include: * If your child was sick with COVID-19, how likely would...their health be severely affected * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

15 month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	20
Caregiver of Children With Medical Complexity (CMC)	18

18 month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	25
Caregiver of Children With Medical Complexity (CMC)	14

21 month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	29
Caregiver of Children With Medical Complexity (CMC)	14

24 month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	26
Caregiver of Children With Medical Complexity (CMC)	19

Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced Primary · 15 month, 18 month, 21 month, 24 month

Parent survey perceived severity construct variables will be: * "If your child was sick with COVID-19, how likely would...their health be permanently reduced" * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely")

15-month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	17
Caregiver of Children With Medical Complexity (CMC)	21

18-month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	20
Caregiver of Children With Medical Complexity (CMC)	19

21-month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	18
Caregiver of Children With Medical Complexity (CMC)	25

24-month

Group	Value	95% CI
Caregiver of Children With Medical Complexity (CMC)	19
Caregiver of Children With Medical Complexity (CMC)	26

Sponsor's own description

The purpose of this research study is to learn about the factors parents consider when deciding whether their child will go to school in-person or attend from home. Investigators are also interested in learning whether access to in-home COVID testing is of value to parents and also whether it affects decision-making about returning to school. This study is being done at UW-Madison in partnership between the Department of Pediatrics and the Department of Industrial and Systems Engineering. A total of 50 caregivers (plus their children with medical complexity) will participate in this study. Additionally, 20 caregivers involved in the study may also be invited to participate in a one-hour, virtual visit in which the caregiver demonstrates and discusses how they perform in-home COVID testing with their child. The results of the study may help researchers advance their understanding of in-home testing strategies for children with medical complexity.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Implementation of School-Based COVID-19 Testing Programs in Underserved Populations.
Haroz EE, Kalb LG, Newland JG, Goldman JL, et al · · 2022 · cited 24× · PMID 34737173 · DOI 10.1542/peds.2021-054268g
Supporting COVID-19 School Safety for Children With Disabilities and Medical Complexity.
Sherby MR, Kalb LG, Coller RJ, DeMuri GP, et al · · 2022 · cited 19× · PMID 34737172 · DOI 10.1542/peds.2021-054268h
School-Academic Partnerships in Support of Safe Return to Schools During the COVID-19 Pandemic.
D'Agostino EM, Haroz EE, Linde S, Layer M, et al · · 2022 · cited 8× · PMID 34737180 · DOI 10.1542/peds.2021-054268c
In-Home COVID-19 Testing for Children With Medical Complexity: Feasibility and Association With School Attendance and Safety Perceptions.
Coller RJ, Kelly MM, Howell KD, Warner G, et al · · 2022 · cited 6× · PMID 36108256 · DOI 10.2105/ajph.2022.306971

Verify or expand the search:

Other trials of BinaxNOW Rapid Antigen System

Trials testing the same drug.

NCT04899245 — ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - COVID-19 Testing in School Wi · NA · completed

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
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NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other University of Wisconsin, Madison trials

Trials by the same sponsor.

NCT07440004 — Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts · Phase 1 · recruiting
NCT07278466 — The COMParing App Support Strategies Study · NA · recruiting
NCT07475104 — Redesigning Surgical Care for Patients in Wisconsin · NA · enrolling by invitation
NCT07470723 — The ORIGIN-FH Study · NA · recruiting
NCT06975657 — Well-being Skills for Reentry · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04895085 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Wisconsin, Madison
Last refreshed: 7 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04895085.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04895085

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of BinaxNOW Rapid Antigen System

Other recruiting trials for COVID-19

Other University of Wisconsin, Madison trials

Verify against primary sources