Participating NC School Districts
Durham, North Carolina, 27707, United States
NCT Number: NCT05052580
Participants in school communities who have been exposed to SARS-CoV-2 will be tested for COVID-19 on the day of exposure (day 1) and at days 3, 5, and 7 following initial known exposure. Mitigation practices including masking, the context of exposure (classroom, school bus, after school sporting event, lunch, etc.), and results of COVID-19 test will be documented.
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Interventional
Not applicable
Durham, North Carolina, 27707, United States
This is a prospective, interventional study with a primary objective of evaluating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission following exposure in Kindergarten through 12th grade schools. Participants will be tested with a COVID-19 testing kit that is Food and Drug Administration (FDA)-authorized under an emergency use authorization (EUA) for non-prescription use for both symptomatic and asymptomatic evaluation in children and adults. Participants who consent to participate in this study will be tested at days 1, 3, 5, and 7 following a known COVID-19 exposure on day 0. If a participant does not know of the exposure until more than one day following they exposure, they will be tested on the day they become aware of the exposure and then resume the aforementioned testing schedule (e.g. participant identifies exposure 3 days after the exposure, test on day 3, day 5, and day 7).
If the COVID-19 tests are negative, the participant will remain in the school environment. A positive COVID-19 test or the development of symptoms on any day after exposure would require isolation according to school, local and state guidelines. Demographic information, daily presence or absence of symptoms, whether the infected person or close contact was masked, setting of the exposure, test results, and school absences will be collected following consent. Data regarding school level mitigation practices will also be collected. Data collected from this study may be combined with school-provided data and publically available community data.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants who consent to participate in this study will be tested at days 1, 3, 5, and 7 following a known COVID-19 exposure on day 0. If the COVID-19 tests are negative, the participant will remain in the school environment. A positive COVID-19 test or the development of symptoms on any day after exposure would require isolation according to school, local and state guidelines.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Exposures That Result in Additional Transmission (TAR = # of positives in TTS close contacts, out of all TTS close contacts)
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Duke University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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