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Rutgers COVID-19 Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336215
Recruitment Status : Active, not recruiting
First Posted : April 7, 2020
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Reynold Panettieri, MD, Rutgers, The State University of New Jersey

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 in healthcare settings and HCW households. We propose to address this hypothesis by recruiting and longitudinally following 500 HCW and 250 age- and sex-matched NHCW within a large academic health system, Rutgers Biomedical and Health Sciences (RBHS). By intensively following participants over a six-month period and collecting serial biospecimens (nasopharyngeal/throat swabs, blood, and saliva) and questionnaire data at nine time points, we uniquely characterize SARS-CoV-2 transmission and risk factors for COVID-19 among HCW and their families.

Condition or disease Intervention/treatment
Coronavirus SARS-CoV-2 Other: Non-Interventional

Detailed Description:

This prospective longitudinal cohort study is comprised of: (1) 500 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) 250 NHCW from Rutgers faculty, staff, and hospital employees without patient contact; and (3) household members of participants who contract SARS-CoV-2 during the study period. 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 participants who test negative for SARS-CoV-2 at baseline, nasopharyngeal/throat swabs, saliva, and blood collection will be collected every two weeks for two months, after which monthly samples will be collected for four additional months (9 visits total, including baseline). Weekly questionnaire data and daily temperature data will be collected from each participant for the first two months of the study. Participants with positive nasopharyngeal/throat swabs or saliva will be immediately referred for medical care or home isolation as medically appropriate. 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, severity of disease, and rates and direction of household transmission.

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 the rate and direction of transmission of SARS-CoV-2 within households.
  7. To determine immune responses to SARS-CoV-2 infection and or vaccinations.

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Study Type : Observational
Actual Enrollment : 865 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study of SARS-CoV-2 Incidence, Transmission, and Disease Severity in Healthcare Workers
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2024

Group/Cohort Intervention/treatment
Healthcare Workers
500 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) . Since rates of asymptomatic carriage, clinical infection, and morbidity likely vary by age and sex, the aim is to recruit 125 HCW in each of the following 4 groups: males ages 20-59; males ages ≥60; females ages 20-59; and females ages ≥60.
Other: Non-Interventional
This non-interventional study poses no additional risks to people with pre-existing conditions.

Non-Healthcare Workers
250 non-healthcare workers (NHCW) from Rutgers faculty, postdoctoral students, students, other trainees, administrators, and staff who do not have patient contact. The aim is to recruit even numbers of NHCW from each of these 4 groups: males ages 20-59; males ages ≥60; females ages 20-59; females ages ≥60.
Other: Non-Interventional
This non-interventional study poses no additional risks to people with pre-existing conditions.

Household Members
Complementing the HCW cohort study, approximately 540 household members in a subset of the participants who test positive and negative for SARS-CoV-2 will be invited to be followed prospectively to assess patterns of viral transmission. The target population will be multigenerational households (e.g., with children and/or parents) from up to 6 infected HCW, 6 infected NHCW, 4 uninfected HCW, and 4 uninfected NHCW at each timepoint. The participant will ask household members to contact research staff if they wish to volunteer for the study. Research coordinators will individually consent adult members of the household for questionnaire and serial samples collection. When children are in the home, parental permission as well as assent for children ages 7 and older (written at ages 12 and older) will be the course of action. The estimated 540 participants assumes 20 houses per timepoint, 9 timepoints, and an average of 3 participants per house.
Other: Non-Interventional
This non-interventional study poses no additional risks to people with pre-existing conditions.




Primary Outcome Measures :
  1. Prevalence [ Time Frame: up to 24 weeks ]
    Prevalence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).

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


Biospecimen Retention:   Samples With DNA
nasopharyngeal or throat swabs, saliva, and blood (for detecting SARS-CoV-2 positivity and immunity)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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;
  • Household members of participants who contract SARS-CoV-2 during the study period.
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.
  • Household members in a subset of the participants who test positive and negative for SARS-CoV-2

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336215


Locations
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United States, New Jersey
Clinical Research Center Rutgers-Robert Wood Johnson Medical School RWJUH East Tower -
New Brunswick, New Jersey, United States, 08901
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Clinical Research Unit Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07103
Rutgers School of Dental Medicine
Newark, New Jersey, United States, 07103
University Hospital
Newark, New Jersey, United States, 07103
Environmental and Occupational Health Sciences Institute
Piscataway, New Jersey, United States, 08854
RUCDR Infinite Biologics
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Jeffrey L Carson, MD Rutgers Biomedical Health Sciences
Principal Investigator: Reynold A Panettieri, MD Rutgers Institute for Translational Medicine and Science
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Reynold Panettieri, MD, Director, Rutgers Institute for Translational Medicine & Science, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT04336215    
Other Study ID Numbers: 2020000679
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infections