Rutgers COVID-19 Cohort Study

May 30, 2023 updated by: Reynold Panettieri, MD, Rutgers, The State University of New Jersey

Cohort Study of SARS-CoV-2 Incidence, Transmission, and Disease Severity in Healthcare Workers

Our long-term goal is to protect the health care workforce (HCW) caring for SARS-CoV-2-infected patients, their families, communities, and the general population. Our specific objective is to rapidly establish a prospective cohort to characterize the factors related to viral transmission and disease severity in a large healthcare system. We addressed this hypothesis by recruiting and longitudinally following 546 HCW and a comparison group of 283 non-HCW within a large academic health system, Rutgers Biomedical and Health Sciences (RBHS). By intensively following participants over a several year period (2020-2024) and collecting serial biospecimens (nasopharyngeal/throat swabs, blood, and saliva) and questionnaire data at multiple time points, we will uniquely characterize SARS-CoV-2 transmission and risk factors for COVID-19 among HCW and our larger academic community.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective longitudinal cohort study is comprised of: (1) 546 HCW from two RBHS hospitals: Robert Wood Johnson University Hospital (RWJUH) in New Brunswick and University Hospital (UH) in Newark ; (both hospital presidents have approved the study) (2) 283 NHCW from Rutgers faculty, staff, and hospital employees without patient contact. At baseline, investigators will obtain nasopharyngeal or throat swabs, saliva, and blood (for detecting SARS-CoV-2 positivity and immunity, respectively) and collect questionnaire data on sociodemographic factors, lifestyle, and medical history. In the first phase of the study, nasopharyngeal/throat swabs, saliva, and blood collection were collected every two weeks for two months, after which monthly samples were collected for four additional months (9 visits total, including baseline). Weekly questionnaire data and daily temperature data was collected from each participant for the first two months of the study. Investigators will calculate and compare incidence rates and risk factors of SARS-CoV-2 positivity and COVID-19 in healthcare workers and non-healthcare workers and assess symptoms and severity of disease. Through additional funding, we will continue to administer follow-up questionnaires and collect additional specimens (primarily for serology) through 2024.

Our specific aims are:

  1. To assess the baseline prevalence of SARS-CoV-2 and COVID-19 in the study population.
  2. To characterize the natural history of SARS-CoV-2 infection in a diverse US workforce, including the incidence of asymptomatic infections and critical illness.
  3. To determine the incidence of SARS-CoV-2 and COVID-19 in healthcare workers compared with non-healthcare workers.
  4. To identify the risk factors for acquiring SARS-CoV-2 and developing COVID-19.
  5. To determine the duration and extent of SARS-CoV-2 shedding.
  6. To determine immune responses to SARS-CoV-2 infection and or vaccinations.

Study Type

Observational

Enrollment (Actual)

829

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
      • New Brunswick, New Jersey, United States, 08901
        • Clinical Research Center Rutgers-Robert Wood Johnson Medical School RWJUH East Tower -
      • Newark, New Jersey, United States, 07103
        • University Hospital
      • Newark, New Jersey, United States, 07103
        • Rutgers School of Dental Medicine
      • Newark, New Jersey, United States, 07103
        • Clinical Research Unit Rutgers New Jersey Medical School
      • Piscataway, New Jersey, United States, 08854
        • Environmental and Occupational Health Sciences Institute
      • Piscataway, New Jersey, United States, 08854
        • RUCDR Infinite Biologics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • HCW from two RBHS hospitals: Robert Wood Johnson University Hospital (RWJUH) in New Brunswick and University Hospital (UH) in Newark ; (both hospital presidents have approved the study)
  • NHCW from Rutgers faculty, staff, and hospital employees without patient contact;

Description

Inclusion Criteria:

  • 20 years and older
  • Hospital and RBHS healthcare workers who have regular direct patient contact (≥3 patients/shift) in emergency rooms or inpatient settings that is expected to continue regularly over the next ≥3 months and who work ≥20 hours in the hospital weekly (residents, clinical fellows, attending physicians, nurse practitioners, physician assistants, registered nurses, license practice nurses, medical technicians, respiratory therapists, physical therapists, clinical pharmacists, dentists, dental hygienists, or dental assistants)
  • Hospital workers who do not have patient contact and non-healthcare from the Rutgers faculty, postdoctoral students, administrators, and staff.

Exclusion Criteria:

  • Previous diagnosis with COVID-19
  • Pregnant or have been diagnosed with a new medical condition in the past 30 days or have had a change in medications in the past 30 days
  • Participants who have been hospitalized in the past 30 days, had and had an emergency room, urgent care visit, or have had surgery.
  • Participants who have a fever on the day of their first visit to the study site (for consent, biospecimen collection, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthcare Workers
546 HCW with high intensity direct patient care from two RBHS-affiliated academic hospitals: Robert Wood Johnson University Hospital (New Brunswick, NJ) and University Hospital (Newark, NJ) and Rutgers School of Dental Medicine (Newark, NJ).
Other: Non-Interventional
This non-interventional study poses no additional risks to people with pre-existing conditions.
Non-Healthcare Workers
283 non-healthcare workers (NHCW) from Rutgers faculty, postdoctoral students, students, other trainees, administrators, and staff who do not have patient contact.
Other: Non-Interventional
This non-interventional study poses no additional risks to people with pre-existing conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence
Time Frame: up to 24 weeks
Prevalence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).
up to 24 weeks
Incidence
Time Frame: up to 24 weeks
Incidence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Jeffrey L Carson, MD, Rutgers Biomedical Health Sciences
  • Principal Investigator: Reynold A Panettieri, MD, Rutgers Institute for Translational Medicine and Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2020

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020000679

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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