Workforce Serosurveillance to Track Long-term Modifications to COVID-19 Exposure Due to Factors in the Built Environment

NCT04542200 | Completed

• 1 other identifier: 20-0668
• Study Type: observational
• Target: 40,132
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• COVID-19 antibodies

  serology testing

  Two years

Interventions

Antibody testing BIOLOGICAL

The antibody results include understanding modifications from environments at work and the community.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Working population of Northwell Health

You may qualify if:

• Northwell Health employees

You may not qualify if:

• Those not employed at Northwell Health

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Feinstein Institutes for Medical Research, Northwell Health

Great Neck, New York, 11021, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Antibody Formation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunity, Active; Adaptive Immunity; Immunity; Immune System Phenomena

Study Officials

• Grace Sembajwe, ScD

  Feinstein Institutes for Medical Research, Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 9, 2020
• Study Start: January 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

US (1)