Prevalence of COVID-19 Antibodies Kingman AZ

Covid19 Clinical Trial

Official title:

Seroprevalence of SARS CoV2 Antibodies Among Adults in Kingman AZ

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533360
• Other study ID #: KRMC 0205
• Status: Completed
• Start date: September 28, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: March 2022
• Source: Kingman Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: May 1, 2021
• Est. primary completion date: October 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
United States	Kingman Regional Medical Center	Kingman	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Kingman Regional Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Retention of SARS-CoV-2 Antibodies among Adults in Kingman AZ	Participants will have a second antibody diagnostic test 2 months following initial enrollment. The concordance between positive tests will then be used to determine the longevity of SARS-CoV-2 antibodies in our community.	2-weeks