SARS-CoV-2 (COVID-19) Immune Surveillance Among a Population Based Sample of Adults in Florida

NCT ID: NCT04596579

Last Updated: 2022-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-17

Study Completion Date

2021-07-25

Brief Summary

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The overall goal of this study is to understand the immune response (IgG) to SARS-CoV-2 to fill critical knowledge gaps in the natural history of this virus and to inform the development of future infection mitigation efforts. The study team aims to assess the prevalence of circulating IgG antibodies to SARS-CoV-2 and the factors associated with sero-prevalence. These data will be used to estimate the total population that has been exposed to the virus (asymptomatic and symptomatic), the proportion of the population that may be protected by natural immunity, and the proportion that is susceptible. Data obtained from this research will be shared with the Florida Department of Health.

Detailed Description

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Conditions

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Coronavirus Infection

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants age 18-34

Up to 300 participants age 18-34 who received an invitation by mail and are free of fever at time of interview.

SARS-CoV-2 Antibody Analysis

Intervention Type DIAGNOSTIC_TEST

10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months.

Weck-cel Swab Collection

Intervention Type DIAGNOSTIC_TEST

A Weck-cel swab will be used to collect secretions from the mucosal epithelium

Web Based Questionnaire

Intervention Type BEHAVIORAL

A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications.

Participants age 35-54

Up to 300 Participants age 35-54 who received an invitation by mail and are free of fever at time of interview.

SARS-CoV-2 Antibody Analysis

Intervention Type DIAGNOSTIC_TEST

10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months.

Weck-cel Swab Collection

Intervention Type DIAGNOSTIC_TEST

A Weck-cel swab will be used to collect secretions from the mucosal epithelium

Web Based Questionnaire

Intervention Type BEHAVIORAL

A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications.

Participants age 55-64

Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview.

SARS-CoV-2 Antibody Analysis

Intervention Type DIAGNOSTIC_TEST

10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months.

Weck-cel Swab Collection

Intervention Type DIAGNOSTIC_TEST

A Weck-cel swab will be used to collect secretions from the mucosal epithelium

Web Based Questionnaire

Intervention Type BEHAVIORAL

A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications.

Participants 65 and over

Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview.

SARS-CoV-2 Antibody Analysis

Intervention Type DIAGNOSTIC_TEST

10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months.

Weck-cel Swab Collection

Intervention Type DIAGNOSTIC_TEST

A Weck-cel swab will be used to collect secretions from the mucosal epithelium

Web Based Questionnaire

Intervention Type BEHAVIORAL

A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications.

Interventions

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SARS-CoV-2 Antibody Analysis

10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months.

Intervention Type DIAGNOSTIC_TEST

Weck-cel Swab Collection

A Weck-cel swab will be used to collect secretions from the mucosal epithelium

Intervention Type DIAGNOSTIC_TEST

Web Based Questionnaire

A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Resident of Hillsborough County, Florida
* 18 years of age or older
* Currently not exhibiting symptoms of SARS-CoV-2 infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna R Giuliano, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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MCC-20635

Identifier Type: -

Identifier Source: org_study_id

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