Prevalence of COVID-19 Antibodies Kingman AZ

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test

• Registration Number: NCT04533360
• Lead Sponsor: Kingman Regional Medical Center

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 Timeline

• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-08-31
• Study Start: 2020-09-28
• Primary Completion: 2020-10-09
• Study Completion: 2021-05-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 566

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Community Cohort 1	VITROS Anti-SARS-CoV-2 IgG test	1000 Participants from the community will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 1.
Community Cohort 2	VITROS Anti-SARS-CoV-2 IgG test	1000 Participants from the community will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 2.
Healthcare Provider Cohort 1	VITROS Anti-SARS-CoV-2 IgG test	500 hospital employees will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 1.
Healthcare Provider Cohort 2	VITROS Anti-SARS-CoV-2 IgG test	500 hospital employees will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 2.

Primary Outcome Measures

Name	Time	Method
Seroprevelence of SARS-CoV-2 Antibodies among Adults in Kingman AZ	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 Outcome Measures

Name	Time	Method
Retention of SARS-CoV-2 Antibodies among Adults in Kingman AZ	2-weeks	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.

Trial Locations

Locations (1)

Kingman Regional Medical Center; 🇺🇸 Kingman, Arizona, United States