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

Completed

• Conditions: Coronavirus Infection
• Interventions: Diagnostic Test: SARS-CoV-2 Antibody Analysis; Diagnostic Test: Weck-cel Swab Collection; Behavioral: Web Based Questionnaire

• Registration Number: NCT04596579
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-16
• Study Start: 2020-10-17
• Study First Posted: 2020-10-22
• Primary Completion: 2021-07-25
• Study Completion: 2021-07-25
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1135

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants age 55-64	Web Based Questionnaire	Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview.
Participants 65 and over	SARS-CoV-2 Antibody Analysis	Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview.
Participants 65 and over	Weck-cel Swab Collection	Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview.
Participants 65 and over	Web Based Questionnaire	Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview.
Participants age 18-34	Weck-cel Swab Collection	Up to 300 participants age 18-34 who received an invitation by mail and are free of fever at time of interview.
Participants age 35-54	Web Based Questionnaire	Up to 300 Participants age 35-54 who received an invitation by mail and are free of fever at time of interview.
Participants age 55-64	Weck-cel Swab Collection	Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview.
Participants age 18-34	SARS-CoV-2 Antibody Analysis	Up to 300 participants age 18-34 who received an invitation by mail and are free of fever at time of interview.
Participants age 18-34	Web Based Questionnaire	Up to 300 participants age 18-34 who received an invitation by mail and are free of fever at time of interview.
Participants age 35-54	SARS-CoV-2 Antibody Analysis	Up to 300 Participants age 35-54 who received an invitation by mail and are free of fever at time of interview.
Participants age 55-64	SARS-CoV-2 Antibody Analysis	Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview.
Participants age 35-54	Weck-cel Swab Collection	Up to 300 Participants age 35-54 who received an invitation by mail and are free of fever at time of interview.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit	At 4 weeks	Participants who tested positive for SARS-CoV-2 antibodies at first study visit will be tested for antibodies to SARS-CoV-2 again at 4 weeks.
Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit	At study start	All participants who respond to study invitation letter will be tested for SARS-CoV-2 antibodies after completing a web-based questionnaire.
Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit	At 3 months	Participants who tested positive for SARS-CoV-2 antibodies at second study visit will be tested for antibodies to SARS-CoV-2 again at 3 months.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States