NCT04595175

Brief Summary

The Investigators propose a multi-center, observational, longitudinal, cohort study of the serology and wellness of HCWs over a year of the COVID-19 pandemic.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 10, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

June 10, 2020

Last Update Submit

October 19, 2020

Conditions

Keywords

SerologyWellnessSARS-CoV-2 IgGSeroprevalenceHealthcare Workers

Outcome Measures

Primary Outcomes (4)

  • Baseline IgG Assay Information

    Seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs

    Baseline

  • Change in IgG Assay Information

    The change in the seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs over one year.

    From Baseline to 3 months, 6 months, 9 months, & 12 months

  • Compare seroprevalence of anti-SARS-CoV-2 IgG antibodies between groups

    Compare seroprevalence of anti-SARS-CoV-2 IgG antibodies in 'front-line' workers and non-'front-line' HCWs

    From Baseline to 3 months, 6 months, 9 months, & 12 months

  • Impact of COVID-19 Pandemic on Perceived Wellness and Job Satisfaction

    Over the 12 months of the study, evaluate the impact of the COVID-19 pandemic on HCW wellness using the Perceived Wellness Survey. Job satisfaction will be measured using a locally developed questionnaire.

    Baseline to 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be enrolled across CommonSpirit Health hospitals and care facilities (all branded as Dignity Health) at five sites in Maricopa County, Arizona: Arizona General Hospital, Chandler Regional Medical Center, Mercy Gilbert Medical Center, St. Joseph's Hospital and Medical Center and St. Joseph's Westgate Medical Center.

You may qualify if:

  • Age greater than or equal to 18 years; and
  • Be an active member of the CommonSpirit Health workforce or medical staff during the COVID-19 pandemic and at the time of enrollment; and
  • Have access to the Internet; and
  • The ability to provide informed consent.

You may not qualify if:

  • Subjects that lack the ability for longitudinal follow-up; and/or

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

One tube of blood will be sent to the appropriate hospital lab for the Abbott IgG testing. The other two tubes of blood will be processed and biobanked. The same tubes will be drawn on the subsequent visits.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Brian Tiffany, MD, PhD

    Chief Medical Officer Dignity Health Arizona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennine Zumbuhl, RN, MSHA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Medical Officer

Study Record Dates

First Submitted

June 10, 2020

First Posted

October 20, 2020

Study Start

June 10, 2020

Primary Completion

June 30, 2021

Study Completion

December 30, 2021

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations