COVID-19NCT04362995
St. Jude Tracking of Viral and Host Factors Associated With COVID-19
An observational study of COVID-19 and Coronavirus Infection, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Coronavirus Infection, Coronavirus
- How many people
- 1,316 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2020to 29 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: St. Jude employees who meet the eligibility criteria.
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
- Employees who did not participate in the original SJTRC study.
- Employees who cannot complete the informed consent process.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: SJTRC-St. Jude Tracking of Viral and Host Factors Associated With COVID-19: A Prospective Adaptive Cohort Study
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
Read more
- 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 immune or receptor polymorphisms associated with response to SARS-CoV-2 infection
- To explore SARS-CoV-2 diversity and specific features in a circumscribed population
- To describe the presence, characteristics, and proportion of short-term re-infection
- To determine if an association between SARS-CoV-2 viral load in nasal swab specimens and COVID-19 symptoms can be identified in a population of adult St. Jude employees who acquire SARS-CoV-2
- To explore the laboratory and clinical response to SARS-CoV-2 vaccine in a population of adult St. Jude employees with and without a history of SARS-CoV-2 infection
Read the 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; the timing of these blood draws and proportion of participants required will be determined by the rate of documented SARS-CoV-2 infection in the cohort according to an adaptive study design. Participants will be tracked for SARS-CoV-2 specific antibodies and CD4, and CD8 T cell responses throughout the period and especially during the early stages after clearance of infection and subsequently to determine the quality and duration of memory responses.
In addition to blood samples, participants will intermittently provide nasal swabs for detection of SARS-CoV-2; this will occur either through a comprehensive proactive employee screening program, or specifically for the purposes of the research study if participants are required to attend campus but are not currently eligible for employee screening. These will determine duration and characteristics of viral shedding and identify reinfection. Seroprevalence estimates and asymptomatic conversion will also be determined.
Individuals with a diagnosis of COVID-19 infection will have two additional blood draws in the acute and convalescent phase to identify acute and late immune responses. These responses will be compared to the essential baseline sample data to characterize the generation of de novo and cross-reactive recall responses.
For those participants receiving vaccination, blood draws will be taken after COVID vaccine (3-8 weeks after completion of 1 or 2 dose course) and at completion of study.
At enrollment, subjects will complete a baseline online personal health and demographic questionnaire, and then monthly brief online health update questionnaires. Throughout the study period, subjects will complete a brief online symptom survey every 2 weeks.
Participants in the original SJTRC study will be asked to reconsent to complete a one-time questionnaire regarding their COVID-19 experience specifically during the time since they went off study. Once this questionnaire is complete, they will be taken off study and receive no further questionnaires related to the original study.
A subset of participants will be invited to re-enroll in a long-term follow-up phase to evaluate long-term immunity and protection against COVID-19 following infection and vaccination. Participants will provide blood samples every 6 months. They will also be invited to provide additional acute and convalescent samples (blood and saliva), if diagnosed with acute COVID-19 during this period. Participants will continue to complete regular questionnaires, but the frequency will decrease to 6 monthly (health questionnaires) and as needed (COVID-19 diagnosis or vaccination).
- Conditions
- COVID-19, Coronavirus Infection, Coronavirus, SARS-CoV-2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Infection | St. Jude Children's Research Hospital employees with SARS-CoV-2 infection | |
| Controls | St. Jude Children's Research Hospital employees uninfected with SARS-CoV-2 infection | |
| Long Term Follow Up (LTFU) | Subset of participants who participated in the original SJTRC study and agree to continue in LTFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of asymptomatic subjects
The proportion of participants who test positive for SARS-CoV-2 infection but remain asymptomatic.
Measured: 1 year from enrollment
Positive CD4 and CD8 cell epitope positive response
A list of CD4 and CD8 cell epitopes with a magnitude change from baseline that is at least twice the standard deviation of the baseline.
Measured: at enrollment, 3 months, 6 months, 9 months and 1 year
Positive CD4 and CD8 cell epitope positive response
A list of CD4 and CD8 cell epitopes with a magnitude change from baseline that is at least twice the standard deviation of the baseline.
Measured: up to 48 months of additional observation in participants who have had COVID-19 or vaccination
Secondary outcomes (5)
Proportion of seroprevalence
The proportion of participants at each time point who have detectable antibodies that recognize SARS-COV-2.
Measured: Baseline, 3 months, 6 months, 9 months and 1 year
T-cell response
For CD8s, T cell responses will be categorized as cytolytic, cytokine producing, or exhausted. For CD4s they will be grouped as Th1, Th2, Tfh, or Th17. Percentages of cells in each category will be summarized at baseline and during SARS-CoV-2 infection.
Measured: Baseline, 3 months, 6 months, 9months, 1 year and 6 monthly for an additional 48 months in participants included in the long-term follow-up arm
Protective antibody responses against SARS-CoV-2 at last follow-up sample
For participants who have enrolled in the long-term follow-up arm of the study, associations between persistent protective antibody responses and clinical and laboratory characteristics will be evaluated by paired tests and regression models.
Measured: up to 48 months of additional observation in participants who have had COVID-19 or vaccination
Change in antibody responses to SARS-CoV-2
For participants who have enrolled in the long-term follow-up arm of the study, changes in antibody levels from baseline in paired samples.
Measured: up to 48 months of additional observation in participants who have had COVID-19 or vaccination
Saliva antibody and cytokine responses to SARS-CoV-2
For participants who have enrolled in the long-term follow-up arm of the study, changes in saliva antibody and cytokine levels from baseline.
Measured: up to 48 months of additional observation in participants who have had COVID-19 or vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start23 Apr 2020
- Primary completion10 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,316 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Georgia, University of Wisconsin, Madison, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Paul G. Thomas, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362995
- Sponsor's protocol ID
- SJTRC
- Other IDs
- NIH1P01AI165077-01, 75N93019C00052, 5R01AI136514-05, 75N93021C00016
- Status last verified
- Aug 2024
- First submitted
- 22 Apr 2020
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schultz-Cherry S, McGargill MA, Thomas PG, Estepp JH, Gaur AH, Allen EK, Allison KJ, Tang L, Webby RJ, Cherry SD, Lin CY, Fabrizio T, Tuomanen EI, Wolf J; SJTRC Investigative Team. Cross-reactive Antibody Response to mRNA SARS-CoV-2 Vaccine After Recent COVID-19-Specific Monoclonal Antibody Therapy. Open Forum Infect Dis. 2021 Aug 10;8(9):ofab420. doi: 10.1093/ofid/ofab420. eCollection 2021 Sep.
PubMed 34557558
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SJTRC-St. Jude Tracking of Viral and Host Factors Associated With COVID-19: A Prospective Adaptive Cohort Study
- ClinicalTrials.gov ID
- NCT04362995
- Acronym / sponsor ID
- SJTRC
- Conditions
- COVID-19, Coronavirus Infection, Coronavirus, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,316 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- University of Georgia, University of Wisconsin, Madison, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 immune or receptor polymorphisms associated with response to SARS-CoV-2 infection
- To explore SARS-CoV-2 diversity and specific features in a circumscribed population
- To describe the presence, characteristics, and proportion of short-term re-infection
- To determine if an association between SARS-CoV-2 viral load in nasal swab specimens and COVID-19 symptoms can be identified in a population of adult St. Jude employees who acquire SARS-CoV-2
- To explore the laboratory and clinical response to SARS-CoV-2 vaccine in a population of adult St. Jude employees with and without a history of 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; the timing of these blood draws and proportion of participants required will be determined by the rate of documented SARS-CoV-2 infection in the cohort according to an adaptive study design. Participants will be tracked for SARS-CoV-2 specific antibodies and CD4, and CD8 T cell responses throughout the period and especially during the early stages after clearance of infection and subsequently to determine the quality and duration of memory responses.
In addition to blood samples, participants will intermittently provide nasal swabs for detection of SARS-CoV-2; this will occur either through a comprehensive proactive employee screening program, or specifically for the purposes of the research study if participants are required to attend campus but are not currently eligible for employee screening. These will determine duration and characteristics of viral shedding and identify reinfection. Seroprevalence estimates and asymptomatic conversion will also be determined.
Individuals with a diagnosis of COVID-19 infection will have two additional blood draws in the acute and convalescent phase to identify acute and late immune responses. These responses will be compared to the essential baseline sample data to characterize the generation of de novo and cross-reactive recall responses.
For those participants receiving vaccination, blood draws will be taken after COVID vaccine (3-8 weeks after completion of 1 or 2 dose course) and at completion of study.
At enrollment, subjects will complete a baseline online personal health and demographic questionnaire, and then monthly brief online health update questionnaires. Throughout the study period, subjects will complete a brief online symptom survey every 2 weeks.
Participants in the original SJTRC study will be asked to reconsent to complete a one-time questionnaire regarding their COVID-19 experience specifically during the time since they went off study. Once this questionnaire is complete, they will be taken off study and receive no further questionnaires related to the original study.
A subset of participants will be invited to re-enroll in a long-term follow-up phase to evaluate long-term immunity and protection against COVID-19 following infection and vaccination. Participants will provide blood samples every 6 months. They will also be invited to provide additional acute and convalescent samples (blood and saliva), if diagnosed with acute COVID-19 during this period. Participants will continue to complete regular questionnaires, but the frequency will decrease to 6 monthly (health questionnaires) and as needed (COVID-19 diagnosis or vaccination).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Infection | – | –St. Jude Children's Research Hospital employees with SARS-CoV-2 infection |
| Controls | – | –St. Jude Children's Research Hospital employees uninfected with SARS-CoV-2 infection |
| Long Term Follow Up (LTFU) | – | –Subset of participants who participated in the original SJTRC study and agree to continue in LTFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- St. Jude employees who meet the eligibility criteria.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- Employees who did not participate in the original SJTRC study.
- Employees who cannot complete the informed consent process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of asymptomatic subjects
Time frame: 1 year from enrollment
The proportion of participants who test positive for SARS-CoV-2 infection but remain asymptomatic.
Positive CD4 and CD8 cell epitope positive response
Time frame: at enrollment, 3 months, 6 months, 9 months and 1 year
A list of CD4 and CD8 cell epitopes with a magnitude change from baseline that is at least twice the standard deviation of the baseline.
Positive CD4 and CD8 cell epitope positive response
Time frame: up to 48 months of additional observation in participants who have had COVID-19 or vaccination
A list of CD4 and CD8 cell epitopes with a magnitude change from baseline that is at least twice the standard deviation of the baseline.
5 secondary outcomes
Proportion of seroprevalence
Time frame: Baseline, 3 months, 6 months, 9 months and 1 year
T-cell response
Time frame: Baseline, 3 months, 6 months, 9months, 1 year and 6 monthly for an additional 48 months in participants included in the long-term follow-up arm
Protective antibody responses against SARS-CoV-2 at last follow-up sample
Time frame: up to 48 months of additional observation in participants who have had COVID-19 or vaccination
Change in antibody responses to SARS-CoV-2
Time frame: up to 48 months of additional observation in participants who have had COVID-19 or vaccination
Saliva antibody and cytokine responses to SARS-CoV-2
Time frame: up to 48 months of additional observation in participants who have had COVID-19 or vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 34557558Schultz-Cherry S, McGargill MA, Thomas PG, Estepp JH, Gaur AH, Allen EK, Allison KJ, Tang L, Webby RJ, Cherry SD, Lin CY, Fabrizio T, Tuomanen EI, Wolf J; SJTRC Investigative Team. Cross-reactive Antibody Response to mRNA SARS-CoV-2 Vaccine After Recent COVID-19-Specific Monoclonal Antibody Therapy. Open Forum Infect Dis. 2021 Aug 10;8(9):ofab420. doi: 10.1093/ofid/ofab420. eCollection 2021 Sep.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- ClinicalTrials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul G. Thomas, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Coronavirus Infection, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of asymptomatic subjects (time frame: 1 year from enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.