Rutgers COVID-19 Cohort Study

NCT04336215 | Unknown

• 1 other identifier: 2020000679
• Study Type: observational
• Target: 829
• Locations: 1 country
• Sites: 7

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.

Conditions

Coronavirus; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Prevalence

  Prevalence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).

  up to 24 weeks

• Incidence

  Incidence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).

  up to 24 weeks

Study Arms (2)

Healthcare Workers

546 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).

Other: Non-Interventional

Non-Healthcare Workers

283 non-healthcare workers (NHCW) from Rutgers faculty, postdoctoral students, students, other trainees, administrators, and staff who do not have patient contact.

Other: Non-Interventional

Interventions

Non-Interventional OTHER

This non-interventional study poses no additional risks to people with pre-existing conditions.

Healthcare Workers; Non-Healthcare Workers

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (7)

Clinical Research Center Rutgers-Robert Wood Johnson Medical School RWJUH East Tower -

New Brunswick, New Jersey, 08901, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Clinical Research Unit Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

Location

University Hospital

Newark, New Jersey, 07103, United States

Location

Environmental and Occupational Health Sciences Institute

Piscataway, New Jersey, 08854, United States

Location

RUCDR Infinite Biologics

Piscataway, New Jersey, 08854, United States

Location

Related Publications (15)

• Colizza V, Barrat A, Barthelemy M, Valleron AJ, Vespignani A. Modeling the worldwide spread of pandemic influenza: baseline case and containment interventions. PLoS Med. 2007 Jan;4(1):e13. doi: 10.1371/journal.pmed.0040013.

  PMID: 17253899 BACKGROUND

• Bai Y, Yao L, Wei T, Tian F, Jin DY, Chen L, Wang M. Presumed Asymptomatic Carrier Transmission of COVID-19. JAMA. 2020 Apr 14;323(14):1406-1407. doi: 10.1001/jama.2020.2565.

  PMID: 32083643 BACKGROUND

• Schulert GS, Zhang M, Fall N, Husami A, Kissell D, Hanosh A, Zhang K, Davis K, Jentzen JM, Napolitano L, Siddiqui J, Smith LB, Harms PW, Grom AA, Cron RQ. Whole-Exome Sequencing Reveals Mutations in Genes Linked to Hemophagocytic Lymphohistiocytosis and Macrophage Activation Syndrome in Fatal Cases of H1N1 Influenza. J Infect Dis. 2016 Apr 1;213(7):1180-8. doi: 10.1093/infdis/jiv550. Epub 2015 Nov 23.

  PMID: 26597256 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Mahase E. Covid-19: WHO declares pandemic because of "alarming levels" of spread, severity, and inaction. BMJ. 2020 Mar 12;368:m1036. doi: 10.1136/bmj.m1036. No abstract available.

  PMID: 32165426 BACKGROUND

• Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.

  PMID: 32113704 BACKGROUND

• Han Y, Yang H. The transmission and diagnosis of 2019 novel coronavirus infection disease (COVID-19): A Chinese perspective. J Med Virol. 2020 Jun;92(6):639-644. doi: 10.1002/jmv.25749. Epub 2020 Mar 12.

  PMID: 32141619 BACKGROUND

• Anderson RM, Heesterbeek H, Klinkenberg D, Hollingsworth TD. How will country-based mitigation measures influence the course of the COVID-19 epidemic? Lancet. 2020 Mar 21;395(10228):931-934. doi: 10.1016/S0140-6736(20)30567-5. Epub 2020 Mar 9. No abstract available.

  PMID: 32164834 BACKGROUND

• Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.

  PMID: 32081636 BACKGROUND

• Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. No abstract available.

  PMID: 32109011 BACKGROUND

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

• Pan X, Chen D, Xia Y, Wu X, Li T, Ou X, Zhou L, Liu J. Asymptomatic cases in a family cluster with SARS-CoV-2 infection. Lancet Infect Dis. 2020 Apr;20(4):410-411. doi: 10.1016/S1473-3099(20)30114-6. Epub 2020 Feb 19. No abstract available.

  PMID: 32087116 BACKGROUND

• Del Rio C, Malani PN. COVID-19-New Insights on a Rapidly Changing Epidemic. JAMA. 2020 Apr 14;323(14):1339-1340. doi: 10.1001/jama.2020.3072. No abstract available.

  PMID: 32108857 BACKGROUND

• Zhang H, Penninger JM, Li Y, Zhong N, Slutsky AS. Angiotensin-converting enzyme 2 (ACE2) as a SARS-CoV-2 receptor: molecular mechanisms and potential therapeutic target. Intensive Care Med. 2020 Apr;46(4):586-590. doi: 10.1007/s00134-020-05985-9. Epub 2020 Mar 3. No abstract available.

  PMID: 32125455 BACKGROUND

• Horton DB, Barrett ES, Roy J, Gennaro ML, Andrews T, Greenberg P, Bruiners N, Datta P, Ukey R, Velusamy SK, Fine D, Honnen WJ, Yin YS, Pinter A, Brooks A, Tischfield J, Hussain S, Jagpal S, Swaminathan S, Parmar V, Reilly N, Gaur S, Panettieri RA, Carson JL, Blaser MJ. Determinants and Dynamics of SARS-CoV-2 Infection in a Diverse Population: 6-Month Evaluation of a Prospective Cohort Study. J Infect Dis. 2021 Oct 28;224(8):1345-1356. doi: 10.1093/infdis/jiab411.

  PMID: 34387310 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal or throat swabs, saliva, and blood (for detecting SARS-CoV-2 positivity and immunity)

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Jeffrey L Carson, MD

  Rutgers Biomedical Health Sciences

  PRINCIPAL INVESTIGATOR

• Reynold A Panettieri, MD

  Rutgers Institute for Translational Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Rutgers Institute for Translational Medicine & Science

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 7, 2020
• Study Start: April 7, 2020
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)