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.
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.
Other: Non-Interventional
This non-interventional study poses no additional risks to people with pre-existing conditions.
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.).
Clinical Research Center Rutgers-Robert Wood Johnson Medical School RWJUH East Tower -
New Brunswick, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Clinical Research Unit Rutgers New Jersey Medical School
Newark, New Jersey, United States
Rutgers School of Dental Medicine
Newark, New Jersey, United States
University Hospital
Newark, New Jersey, United States
Environmental and Occupational Health Sciences Institute
Piscataway, New Jersey, United States
RUCDR Infinite Biologics
Piscataway, New Jersey, United States