Skip to main content
Clinical Trials/NCT04533360
NCT04533360CompletedNot Applicable

Seroprevalence of SARS CoV2 Antibodies Among Adults in Kingman AZ

Kingman Regional Medical Center1 site in 1 country566 target enrollmentStarted: September 28, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
566
Locations
1
Primary Endpoint
Seroprevelence of SARS-CoV-2 Antibodies among Adults in Kingman AZ

Study Overview

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.

Detailed Description

Adult participants aged 18 or greater will be recruited from the greater Kingman AZ area through social media, radio, newspaper, and a press release. Participants self-selected inclusion in the study by calling into a COVID-19 hotline and will be included in the sample data following self-report of absence of covid-19 symptoms. Participants will be scheduled for testing on the weeks of 09/28/2020 and 10/05/2020. Upon recruitment, participants will be asked to complete a demographic and behavioral survey, assessing socioeconomic status, interpersonal interactions, personal protective measures, and COVID-19 symptomology in the preceding two months. Two months after initial testing, all negative SARS-CoV-2-specific antibodies participants will be contacted for repeat testing and surveying.

SARS-CoV-2-specific antibodies will be tested using a lateral flow immunoassay with the VITROS Anti-SARS-CoV-2 IgG test (Ortho-Clinical Diagnostics, Inc.) under the Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). The diagnostic sensitivity of the immunoassay was 87.5% and specificity was 100%. The positive and negative predictive value with a prevalence of 5% in the community was 100% and 99.3% respectively. All data will be de-identified and stored in a password protected file only visible to study investigators. All positive results were called back to participants by the lead author.

Data obtained was then used to estimate the population prevalence of SARS-CoV-2-specific antibodies in the Kingman, Arizona population. Unweighted and weighted proportions of positive tests were calculated to match the 2018 census on sex, race, education, and income. Confidence intervals for unweighted data will be estimated using exact binomial models and for weighted and adjusted estimates using bootstrap methods. All data was analyzed using SPSS.

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Adults aged 18+
  • Resident of Mohave County AZ

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 2-weeks

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

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

John Ashurst

Emergency Medicine Residency Program Director

Kingman Regional Medical Center

Study Sites (1)

Loading locations...

Similar Trials