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NCT04362995 · ClinicalTrials.gov registry record
St. Jude Tracking of Viral and Host Factors Associated With COVID-19
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 1,316
- Enrollment target
NCT04362995: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT04362995 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 1,316 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04362995 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 1,316 participants
- Enrollment target
Study 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. Primary Objectives * To estimate the proportion of asymptomatic infection with SARS-CoV-2 infection in a population of SARS-CoV-2-naïve adult St. Jude employees * To comprehensively map CD4 and CD8 T cell epitopes and response magnitudes to SARS-CoV-2 infection in a population of SARS-CoV-2-naïve adult St. Jude employees who acquire SARS-CoV-2 infection * To measure changes in the CD4 and CD8 response magnitude and function to SARS-CoV-2 infection and/or vaccination in a population of St. Jude employees for up to 48 months after infection and/or vaccination. Secondary Objectives * To establish seroprevalence of SARS-CoV-2-specific antibodies at baseline, and identify the rate of seroconversion to SARS-CoV-2 in a population of presumably naïve adult St. Jude employees * To identify features of T cell responses at baseline and during SARS-CoV-2 infection that are associated with protection against symptomatic or severe COVID-19 disease in a population of adult St. Jude employees * To identify risk factors for long-term protection against COVID-19 in a population of adult St. Jude employees * To evaluate changes in antibody responses to SARS-CoV-2 in a population of St. Jude employees for up to 48 months after SARS-CoV-2 infection and/or vaccination. * To evaluate the saliva antibody and cytokine response to SARS-CoV-2 infection and/or vaccination and identify characteristics that predict protection from subsequent SARS-CoV-2 infection among a population of St. Jude employees followed for up to 48 months after SARS-CoV-2 infection and/or vaccination. * To measure changes in saliva antibody responses to SARS-CoV-2 for up to 48 months after SARS-CoV-2 infection and/or vaccination. Exploratory Objectives * To establish additional immunological features including host im
Primary Outcome
The proportion of participants who test positive for SARS-CoV-2 infection but remain asymptomatic.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,316 participants |
| Start Date | 2020-04-23 |
| Est. Completion | 2024-07-29 |
What the finished NCT04362995 record still lists
NCT04362995 is an observational study that tracks outcomes without assigning an intervention. Its 1,316 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT04362995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04362995 about?
NCT04362995 is a clinical study titled "St. Jude Tracking of Viral and Host Factors Associated With COVID-19". 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. Primary Objectives * To estimate the proportion of asymptomatic infection with SARS-CoV-2 infectio...
What is the current status of trial NCT04362995?
This trial is currently completed. The enrollment target is 1,316 participants. The study started on 2020-04-23. Estimated completion is 2024-07-29.
Who is sponsoring clinical trial NCT04362995?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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