SARS-CoV-2 (COVID-19) Immune Surveillance Among a Population Based Sample of Adults in Florida
SARS-CoV-2 Immune Surveillance Among a Population Based Sample of Adults in Florida
1 other identifier
observational
1,135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2020
CompletedStudy Start
First participant enrolled
October 17, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2021
CompletedOctober 3, 2022
September 1, 2022
9 months
October 16, 2020
September 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit
All participants who respond to study invitation letter will be tested for SARS-CoV-2 antibodies after completing a web-based questionnaire.
At study start
Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit
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.
At 4 weeks
Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit
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.
At 3 months
Study Arms (4)
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.
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.
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.
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.
Interventions
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.
A Weck-cel swab will be used to collect secretions from the mucosal epithelium
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.
Eligibility Criteria
Community Sample
You may qualify if:
- Resident of Hillsborough County, Florida
- years of age or older
- Currently not exhibiting symptoms of SARS-CoV-2 infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna R Giuliano, PhD
Moffitt Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 22, 2020
Study Start
October 17, 2020
Primary Completion
July 25, 2021
Study Completion
July 25, 2021
Last Updated
October 3, 2022
Record last verified: 2022-09