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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04336215
• Other study ID #: 2020000679
• Status: Active, not recruiting
• Start date: April 7, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 829
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• SARS-CoV-2

Intervention

Other:
• Non-Interventional
This non-interventional study poses no additional risks to people with pre-existing conditions.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence	Prevalence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).	up to 24 weeks
Primary	Incidence	Incidence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).	up to 24 weeks