Clinical trial NCT04336215: Rutgers COVID-19 Cohort Study
Official title: Cohort Study of SARS-CoV-2 Incidence, Transmission, and Disease Severity in Healthcare Workers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus
SARS-CoV-2
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 829
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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;

Brief summary: 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.

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Prevalence
timeFrame: up to 24 weeks
measure: Incidence
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Clinical Research Center Rutgers-Robert Wood Johnson Medical School RWJUH East Tower -
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Newark
country: United States
facility: Clinical Research Unit Rutgers New Jersey Medical School
state: New Jersey
city: Newark
country: United States
facility: Rutgers School of Dental Medicine
state: New Jersey
city: Newark
country: United States
facility: University Hospital
state: New Jersey
city: Piscataway
country: United States
facility: Environmental and Occupational Health Sciences Institute
state: New Jersey
city: Piscataway
country: United States
facility: RUCDR Infinite Biologics
state: New Jersey
Study officials:
affiliation: Rutgers Biomedical Health Sciences
name: Jeffrey L Carson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers Institute for Translational Medicine and Science
name: Reynold A Panettieri, MD
role: PRINCIPAL_INVESTIGATOR
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