Covid19 Clinical Trial
Official title:
Coronavirus Disease 2019 (COVID-19) Surveillance and Exposure Testing in School Communities
NCT number | NCT04831866 |
Other study ID # | Pro00108049 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 26, 2021 |
Est. completion date | January 31, 2022 |
Verified date | April 2022 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 4000 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Data from all participating school communities will be included in this study (no inclusion/exclusion criteria will be assessed). Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Durham Charter Schools | Durham | North Carolina |
United States | Iredell-Statesville Schools | Statesville | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Surveillance Cohort. | Proportion of students/staff with positive SARS-CoV-2 test identified by surveillance testing. | 2 years | |
Primary | Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Exposure Cohort. | Proportion of students/staff with positive SARS-CoV-2 test following within-school exposure. | 2 years | |
Primary | Describe return to school outcomes in Kindergarten through 12th grade schools in Surveillance Cohort. | Proportion of students who return to in-person education in Fall 2021, Spring 2022, and Fall 2022 from participating schools conducting surveillance testing compared to districts without testing. | 2 years | |
Primary | Describe return to school outcomes in Kindergarten through 12th grade schools in Exposure Cohort. | Mean time to return-to-school after SARS-CoV-2 exposure in the month after initiation of the school-provided testing program compared to the month prior to initiation of the school-provided testing program. | 2 years |
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