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