Covid19NCT04542200
Workforce Serosurveillance to Track Long-term Modifications to COVID-19 Exposure Due to Factors in the Built Environment
An observational study of Covid19, run by Northwell Health at 1 site in United States.
Trial summary
The goal, with this study, is to leverage Northwell Health System's diverse workforce and robust testing structures, to contribute data-driven, evidence-based strategies to better understand the sustained prevalence of antibodies and how conferred immunity may be modified by environmental factors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Antibody testing
- How many people
- 40,132 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Working population of Northwell Health
Who may be able to join
- Northwell Health employees
Who cannot join
- Those not employed at Northwell Health
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institutes for Medical Research, Northwell Health
Great Neck, New York, 11021
About this study
The goal, with this study, is to leverage Northwell Health System's diverse workforce and robust testing structures, to contribute data-driven, evidence-based strategies to better understand the sustained prevalence of antibodies and how conferred immunity may be modified by environmental factors. The objective is to investigate the COVID-19/SARS-CoV-2 disease prevalence and trajectory over time, by conducting follow-up antibody testing on employees who consented to participate in research during the initial workforce offering. From 70,812 employees contacted, 46,117 were tested and received initial results. Of those participants, approximately, 32,000 agreed to be re-contacted, and 34,000 consented to research. The investigators plan to conduct an additional five rounds of testing that would sample individuals over a two-year period. This study is significant because it leverages Northwell Health's advanced laboratory systems to conduct serosurveillance of antibodies to COVID-19/SARS-CoV-2 across a large and diverse workforce, while taking into account the contextual environmental and occupational exposures that may modify continued immunity to the virus. Northwell Health's employee health services (EHS) is poised to act quickly to adapt policies and practices, where needed, to protect the workforce. The study is also innovative because it will be linking work environment and community measures with COVID-19 seropositive prevalence patterns over time, to build a better understanding of the disease and its controls at the population level. The expected outcomes include serial serology results as a measure of full or partial short-term (6 months) and long-term (2 year) immunity to re-infection and recognition of local environmental factors (e.g., building ventilation rates, zip code, air quality indicators) that could modify this immunity and assist with protecting the workforce and surrounding community. These results could inform national and global policies.
Read the detailed description
The objective of this study is to understand the COVID-19/SARS-CoV-2 disease incidence, prevalence, and trajectory over time, by conducting follow-up antibody testing on employees by first following up with the approximately 5,600 team members who were positive and then extending the invitation to the remaining team members (approximately 65,212).
Aim 1) Follow those who tested positive during prior institutional antibody testing to better understand whether IgG or total antibody measures confer continued immunity; hypothesis 1 is that prior infection will be protective and that restricting testing to prior positives, reduces impact of false positive results due to low prevalence populations. Over a 1.5 year period, testing will be repeated on seropositive individuals in January 2021, May 2021, September of 2021, January 2022, and May 2022.
The results will be to document antibody seropositivity and continued presence of immunity over time. The study investigators will invite those positive Northwell team members to participate in a research study that has the aim of testing for continued presence of antibodies to COVID-19, to understand trends over time.
Aim 2) Continue to document seroconversion rates and distribution of exposure to COVID-19 across the entire remaining workforce; hypothesis 2 is that employees will have lower rates than the general population, even though false positive serology results will be highly dependent upon New York State positive prevalence rates. Over the same 1.5 year period as in Aim 1, testing will be repeated for all workforce participants who previously tested negative and others interested in participating for the first time in May 2021 (or September 2021) and May 2022.
Aim 3) Track any associations between engineering, administrative, and personal protective equipment (PPE) policies across the health system and whether these continue to be protective and adapt to disease/viral behavior over time; hypothesis 3 is that Northwell Health policies are proactive and protective and that co-exposures to environmental factors in the workplace and community are measurable and remediable with respect to their effects on COVID-19 infection rates. The investigators propose to complete three things. First, they will be linking job title, department, and industry codes from participant records, with occupational indices of workplace exposure, such as O*Net. This will create a job or task exposure matrix (JEM) for job groups in the Northwell Health system. This JEM will reflect conventional understanding of job level exposure risk estimates to work stressors that may be physical (e.g., heavy loads), psychosocial (e.g., job demand/control), noise, and chemical (e.g., peracetic acid cleaners). Second, they will link departmental level policy information on personal protective equipment (PPE) for each job/task; administrative policies on work hours for the job and chemicals used for infection control at the unit level; and engineering (ventilation rates) at the building and unit level (e.g., air changes per hour and occupancy limits). This institutional policy information will be gathered from January 2021 to each wave of data collection. Any changes in policy will be documented and the most recent policy will be linked with the job title information. Third, the investigators will integrate community variable census information (at the census tract or zip code level) on neighborhood air quality, poverty rates, language predominance, nativity (US or other), and household density. The study will include travel distance to work and transportation mode.
The investigators anticipate that findings from this work, particularly from Aim 3, have implications that extend to communities across New York State (Northwell Health is the largest employer in New York and its employee residences and work locations span every county). They also believe that this work has broader national and international relevance, as the world continues global efforts to navigate a built environment in which SARS-CoV-2 now exists in a pandemic. The strengths of this study are that it accesses a large population sample of 70,812 people that is diverse and also self-contained, whereby, multiple work, home, and environmental factors can be measured alongside trajectories in COVID-19 prevalence. The population is economically and culturally diverse, even by global standards, and includes Queens County that has recorded some of the highest seropositivity rates to date.
- Conditions
- Covid19
- Being tested
- Antibody testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibody testingBiological
The antibody results include understanding modifications from environments at work and the community.
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 antibodies
serology testing
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Jan 2021
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- 40,132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace Sembajwe, ScD, Principal investigator, Feinstein Institutes for Medical Research, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542200
- Sponsor's protocol ID
- 20-0668
- Status last verified
- Feb 2023
- First submitted
- 8 Sep 2020
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workforce Serosurveillance to Track Long-term Modifications to COVID-19 Exposure Due to Factors in the Built Environment
- ClinicalTrials.gov ID
- NCT04542200
- Acronym / sponsor ID
- 20-0668
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,132 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Sep 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.
The goal, with this study, is to leverage Northwell Health System's diverse workforce and robust testing structures, to contribute data-driven, evidence-based strategies to better understand the sustained prevalence of antibodies and how conferred immunity may be modified by environmental factors. The objective is to investigate the COVID-19/SARS-CoV-2 disease prevalence and trajectory over time, by conducting follow-up antibody testing on employees who consented to participate in research during the initial workforce offering. From 70,812 employees contacted, 46,117 were tested and received initial results. Of those participants, approximately, 32,000 agreed to be re-contacted, and 34,000 consented to research. The investigators plan to conduct an additional five rounds of testing that would sample individuals over a two-year period. This study is significant because it leverages Northwell Health's advanced laboratory systems to conduct serosurveillance of antibodies to COVID-19/SARS-CoV-2 across a large and diverse workforce, while taking into account the contextual environmental and occupational exposures that may modify continued immunity to the virus. Northwell Health's employee health services (EHS) is poised to act quickly to adapt policies and practices, where needed, to protect the workforce. The study is also innovative because it will be linking work environment and community measures with COVID-19 seropositive prevalence patterns over time, to build a better understanding of the disease and its controls at the population level. The expected outcomes include serial serology results as a measure of full or partial short-term (6 months) and long-term (2 year) immunity to re-infection and recognition of local environmental factors (e.g., building ventilation rates, zip code, air quality indicators) that could modify this immunity and assist with protecting the workforce and surrounding community. These results could inform national and global policies.
Detailed description
The objective of this study is to understand the COVID-19/SARS-CoV-2 disease incidence, prevalence, and trajectory over time, by conducting follow-up antibody testing on employees by first following up with the approximately 5,600 team members who were positive and then extending the invitation to the remaining team members (approximately 65,212).
Aim 1) Follow those who tested positive during prior institutional antibody testing to better understand whether IgG or total antibody measures confer continued immunity; hypothesis 1 is that prior infection will be protective and that restricting testing to prior positives, reduces impact of false positive results due to low prevalence populations. Over a 1.5 year period, testing will be repeated on seropositive individuals in January 2021, May 2021, September of 2021, January 2022, and May 2022.
The results will be to document antibody seropositivity and continued presence of immunity over time. The study investigators will invite those positive Northwell team members to participate in a research study that has the aim of testing for continued presence of antibodies to COVID-19, to understand trends over time.
Aim 2) Continue to document seroconversion rates and distribution of exposure to COVID-19 across the entire remaining workforce; hypothesis 2 is that employees will have lower rates than the general population, even though false positive serology results will be highly dependent upon New York State positive prevalence rates. Over the same 1.5 year period as in Aim 1, testing will be repeated for all workforce participants who previously tested negative and others interested in participating for the first time in May 2021 (or September 2021) and May 2022.
Aim 3) Track any associations between engineering, administrative, and personal protective equipment (PPE) policies across the health system and whether these continue to be protective and adapt to disease/viral behavior over time; hypothesis 3 is that Northwell Health policies are proactive and protective and that co-exposures to environmental factors in the workplace and community are measurable and remediable with respect to their effects on COVID-19 infection rates. The investigators propose to complete three things. First, they will be linking job title, department, and industry codes from participant records, with occupational indices of workplace exposure, such as O*Net. This will create a job or task exposure matrix (JEM) for job groups in the Northwell Health system. This JEM will reflect conventional understanding of job level exposure risk estimates to work stressors that may be physical (e.g., heavy loads), psychosocial (e.g., job demand/control), noise, and chemical (e.g., peracetic acid cleaners). Second, they will link departmental level policy information on personal protective equipment (PPE) for each job/task; administrative policies on work hours for the job and chemicals used for infection control at the unit level; and engineering (ventilation rates) at the building and unit level (e.g., air changes per hour and occupancy limits). This institutional policy information will be gathered from January 2021 to each wave of data collection. Any changes in policy will be documented and the most recent policy will be linked with the job title information. Third, the investigators will integrate community variable census information (at the census tract or zip code level) on neighborhood air quality, poverty rates, language predominance, nativity (US or other), and household density. The study will include travel distance to work and transportation mode.
The investigators anticipate that findings from this work, particularly from Aim 3, have implications that extend to communities across New York State (Northwell Health is the largest employer in New York and its employee residences and work locations span every county). They also believe that this work has broader national and international relevance, as the world continues global efforts to navigate a built environment in which SARS-CoV-2 now exists in a pandemic. The strengths of this study are that it accesses a large population sample of 70,812 people that is diverse and also self-contained, whereby, multiple work, home, and environmental factors can be measured alongside trajectories in COVID-19 prevalence. The population is economically and culturally diverse, even by global standards, and includes Queens County that has recorded some of the highest seropositivity rates to date.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Working population of Northwell Health
Key inclusion criteria (1 listed)
- Northwell Health employees
Key exclusion criteria (1 listed)
- Those not employed at Northwell Health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibody testingThe antibody results include understanding modifications from environments at work and the community. | Biological | – |
Primary outcome
COVID-19 antibodies
Time frame: Two years
serology testing
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 6 Feb 2023.
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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.
Grace Sembajwe, ScD principal investigator
Feinstein Institutes for Medical Research, Northwell Health
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 Covid19, run by Northwell Health 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 1 inclusion and 1 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 6 Feb 2023. 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?
COVID-19 antibodies (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2023.