NCT04533360

Brief Summary

The COVID-19 disease outbreak is a historic event that has challenged medical systems in the United States. Currently, most reports of confirmed cases rely on the testing of symptomatic patients. These estimates of confirmed cases miss individuals who have recovered from infection, with mild or no symptoms, and individuals with symptoms who have not been tested due to the limited availability of tests. We are conducting serology testing within the community for SARS-CoV-2-specific antibodies through a serologic test could give insight into past COVID-19 infections within our community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
566

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

September 28, 2020

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

11 days

First QC Date

August 28, 2020

Last Update Submit

March 16, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Seroprevelence of SARS-CoV-2 Antibodies among Adults in Kingman AZ

    A sample from the population of Kingman AZ will be used to determine the epidemiology of COVID-19 spread throughout Kingman AZ.

    2-weeks

Secondary Outcomes (1)

  • Retention of SARS-CoV-2 Antibodies among Adults in Kingman AZ

    2-weeks

Study Arms (4)

Community Cohort 1

1000 Participants from the community will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 1.

Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test

Community Cohort 2

1000 Participants from the community will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 2.

Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test

Healthcare Provider Cohort 1

500 hospital employees will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 1.

Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test

Healthcare Provider Cohort 2

500 hospital employees will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 2.

Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test

Interventions

VITROS Anti-SARS-CoV-2 IgG testDIAGNOSTIC_TEST

The VITROS Anti-SARS-CoV-2 IgG test is a lateral flow immunoassay produced by Ortho-Clinical Diagnostics Inc.

Community Cohort 1Community Cohort 2Healthcare Provider Cohort 1Healthcare Provider Cohort 2

Eligibility Criteria

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

\~30,000 individuals inhabit Kingman AZ across 7,854 households, out of which 30.1% had children under the age of 18 living with them, 54.6% were married couples living together, 10.1% had a female householder with no husband present, and 30.9% were non-families. 25.5% of all households were made up of individuals, and 11.7% had someone living alone who was 65 years of age or older.

You may qualify if:

  • Adults aged 18+
  • Resident of Mohave County AZ

You may not qualify if:

  • Children under 18yo
  • Previous positive SARS-CoV2- Antibody Test
  • Active symptoms of respiratory Illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingman Regional Medical Center

Kingman, Arizona, 86409, United States

Location

Related Publications (3)

  • Paul R, Arif AA, Adeyemi O, Ghosh S, Han D. Progression of COVID-19 From Urban to Rural Areas in the United States: A Spatiotemporal Analysis of Prevalence Rates. J Rural Health. 2020 Sep;36(4):591-601. doi: 10.1111/jrh.12486. Epub 2020 Jun 30.

    PMID: 32602983BACKGROUND

  • Peters DJ. Community Susceptibility and Resiliency to COVID-19 Across the Rural-Urban Continuum in the United States. J Rural Health. 2020 Jun;36(3):446-456. doi: 10.1111/jrh.12477. Epub 2020 Jun 16.

    PMID: 32543751BACKGROUND

  • Santarelli A, Lalitsasivimol D, Bartholomew N, Reid S, Reid J, Lyon C, Wells J, Ashurst J. The seroprevalence of SARS-CoV-2 in a rural southwest community. J Osteopath Med. 2021 Feb 1;121(2):199-210. doi: 10.1515/jom-2020-0287.

    PMID: 33567087DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Anthony J Santarelli, PhD

    Kingman Healthcare Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Medicine Residency Program Director

Study Record Dates

First Submitted

August 28, 2020

First Posted

August 31, 2020

Study Start

September 28, 2020

Primary Completion

October 9, 2020

Study Completion

May 1, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)