NCT04831866

COVID-19 Surveillance and Exposure Testing in School Communities

Completed Last updated 13 April 2022

What this trial tests

trial in Covid19 in 4,000 participants. Completed in 31 January 2022.

Timeline

26 April 2021

Primary endpoint
31 January 2022

31 January 2022

Quick facts

Lead sponsor	Duke University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	4,000
Start date	26 April 2021
Primary completion	31 January 2022
Estimated completion	31 January 2022
Sites	2 locations across United States

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Duke University

Who can join

Eligibility, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, observational study of COVID-19 surveillance and exposure testing in school communities. Participating school communities are providing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests to students and staff at their schools per school, local, and national guidelines. This study will combine data received from the schools with data collected directly from participants to guide analysis of the co-primary objectives. Participants will be grouped into two different cohorts, depending on each school's SARS-CoV-2 test administration practices.

Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff.

Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection.

Publications & conference data

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

1. 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
2. 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
3. SARS-CoV-2 Screening Testing Programs for Safe In-person Learning in K-12 Schools.
   Kalu IC, Zimmerman KO, Goldman JL, Keener Mast D, et al · · 2023 · cited 9× · PMID 36412278 · DOI 10.1093/jpids/piac119
4. 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