Status:
COMPLETED
St. Jude Tracking of Viral and Host Factors Associated With COVID-19
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
University of Georgia
University of Wisconsin, Madison
Conditions:
COVID-19
Coronavirus Infection
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective adaptive cohort study of St. Jude employees to determine the rate of SARS-CoV-2 infections that are asymptomatic and to evaluate immunological responses to SARS-CoV-2 infection. ...
Detailed Description
Naive individuals will contribute a baseline blood sample at enrollment. Subsequent routine blood draws will occur to determine the proportion of participants who have asymptomatically seroconverted; ...
Eligibility Criteria
Inclusion
- Adult St. Jude employees (Age ≥ 18 years of age) who are presumed to be SARS- CoV-2 naive, or have a recent diagnosis of COVID-19, and volunteer to participate.
- Willing to undergo blood draws on up to 5 occasions during the study.
- Receiving approximately twice-weekly SARS-CoV-2 screening by Occupational Health, or willing to provide up to twice weekly nasal self-swabs if attending campus.
- Have access to a personal smartphone that is able to receive and respond to text messages for data collection.
- Has ready access to the internet to log personal study information into the REDCap database.
- Self-identified as able to speak and read English well enough to understand the consent process and survey forms, and to report symptoms.
- Inclusion Criteria for LTFU arm:
- Adult St. Jude employees (age ≥ 18 years of age) who participated in the original SJTRC study.
- Willing to undergo blood draws on up to five occasions during the LTFU arm. Willing to provide saliva samples at acute and convalescent episodes.
- Have access to a personal smartphone that is able to receive and respond to text messages for data collection.
- Have ready access to the internet to log personal study information into the REDCap database.
- Self-identified as able to speak and read English well enough to understand the consent process and questionnaires, and to report symptoms.
Exclusion
- Employees who are first-degree relatives of, or directly or indirectly report up to, the PI or any of the clinical study investigators who will have access to participant identities.
- Employees who cannot complete the informed consent process.
- Exclusion Criteria for LTFU arm:
- Employees who did not participate in the original SJTRC study.
- Employees who cannot complete the informed consent process.
Key Trial Info
Start Date :
April 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 29 2024
Estimated Enrollment :
1316 Patients enrolled
Trial Details
Trial ID
NCT04362995
Start Date
April 23 2020
End Date
July 29 2024
Last Update
August 12 2024
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105