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BinaxNOW Rapid Antigen System for COVID-19

N/A
Waitlist Available
Led By Ryan Coller, MD, MPH
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month
Awards & highlights

Study Summary

This trial will help increase the safe return of children with medical complexity to school by testing different strategies for COVID-19 testing and identifying parent and staff perceptions of testing and school attendance.

Eligible Conditions
  • COVID-19
  • Children With Medical Complexity
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in COVID test rate at school: Number of total tests completed as compared to number of tests expected
Change in Cues: Has a teacher or staff member encouraged child to attend school in-person? (Y/N)
Change in False-positive rate: number of negative confirmatory Polymerase chain reaction (PCR) as compared to total PCR run for COVID-19 testing
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: School StaffExperimental Treatment1 Intervention
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing.
Group II: Parent/Child with Children with medical complexity (CMC)Experimental Treatment1 Intervention
65 children and their parents will be recruited to participate. School staff will send a letter to all parents with children enrolled in the Waisman Early Childhood Program (WECP) inviting them to participate. Families new to the school or who initially decline participation and then reconsider may join at any time. Participants will also be offered the option of as needed symptomatic home testing. Additionally, parents who are vaccinated will be asked to participate in testing. Siblings may be enrolled in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BinaxNOW Rapid Antigen System
2021
N/A
~80

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,952 Previous Clinical Trials
2,660,773 Total Patients Enrolled
12 Trials studying COVID-19
63,550 Patients Enrolled for COVID-19
University of Wisconsin, MadisonLead Sponsor
1,176 Previous Clinical Trials
3,011,935 Total Patients Enrolled
14 Trials studying COVID-19
1,667,134 Patients Enrolled for COVID-19
Ryan Coller, MD, MPHPrincipal InvestigatorUniversity of Wisconsin, Madison
3 Previous Clinical Trials
415 Total Patients Enrolled
1 Trials studying COVID-19
51 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still looking for participants in this experiment?

"Data from clinicaltrials.gov indicates that this trial is not currently open to any new enrollees, with the initial posting date being May 4th 2021 and the last update occuring on August 15 2022. However, there are 1037 other medical studies recruiting patients at present time."

Answered by AI
~19 spots leftby Mar 2025