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

Study Overview
=================
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.

Official Title
-----------------
SARS-CoV-2 Immune Surveillance Among a Population Based Sample of Adults in Florida

Conditions
-----------------
Coronavirus Infection

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV-2 Antibody Analysis
* Diagnostic Test: Weck-cel Swab Collection
* Behavioral: Web Based Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident of Hillsborough County, Florida 18 years of age or older Currently not exhibiting symptoms of SARS-CoV-2 infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants age 18-34<br>Up to 300 participants age 18-34 who received an invitation by mail and are free of fever at time of interview. | Diagnostic Test: SARS-CoV-2 Antibody Analysis<br>* 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.<br>Diagnostic Test: Weck-cel Swab Collection<br>* A Weck-cel swab will be used to collect secretions from the mucosal epithelium<br>Behavioral: Web Based Questionnaire<br>* 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.<br>|
| Participants age 35-54<br>Up to 300 Participants age 35-54 who received an invitation by mail and are free of fever at time of interview. | Diagnostic Test: SARS-CoV-2 Antibody Analysis<br>* 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.<br>Diagnostic Test: Weck-cel Swab Collection<br>* A Weck-cel swab will be used to collect secretions from the mucosal epithelium<br>Behavioral: Web Based Questionnaire<br>* 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.<br>|
| Participants age 55-64<br>Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview. | Diagnostic Test: SARS-CoV-2 Antibody Analysis<br>* 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.<br>Diagnostic Test: Weck-cel Swab Collection<br>* A Weck-cel swab will be used to collect secretions from the mucosal epithelium<br>Behavioral: Web Based Questionnaire<br>* 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.<br>|
| Participants 65 and over<br>Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview. | Diagnostic Test: SARS-CoV-2 Antibody Analysis<br>* 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.<br>Diagnostic Test: Weck-cel Swab Collection<br>* A Weck-cel swab will be used to collect secretions from the mucosal epithelium<br>Behavioral: Web Based Questionnaire<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID -19, SARC-CoV-2