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临床试验/NCT04533360
NCT04533360已完成不适用

Seroprevalence of SARS CoV2 Antibodies Among Adults in Kingman AZ

Kingman Regional Medical Center1 个研究点 分布在 1 个国家目标入组 566 人开始时间: 2020年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
566
试验地点
1
主要终点
Seroprevelence of SARS-CoV-2 Antibodies among Adults in Kingman AZ

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18+
  • Resident of Mohave County AZ

排除标准

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

结局指标

主要结局

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

时间窗: 2-weeks

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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Ashurst

Emergency Medicine Residency Program Director

Kingman Regional Medical Center

研究点 (1)

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