Rutgers COVID-19 Cohort Study

SARS-CoV-2 Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• SARS-CoV-2

• NCT number: NCT04336215
• Study type: Observational
• Source: Rutgers, The State University of New Jersey
• Status: Active, not recruiting
• Start date: April 7, 2020
• Completion date: August 31, 2024