## Protocol Section
### Identification Module
**NCT ID:** NCT04596579

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

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

#### Organization Study ID Info
**ID:** MCC-20635
#### Organization
**Class:** OTHER
**Full Name:** H. Lee Moffitt Cancer Center and Research Institute
### Status Module
#### Completion Date
**Date:** 2021-07-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-03

**Type:** ACTUAL

**Last Update Submit Date:** 2022-09-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-07-25

**Type:** ACTUAL

#### Start Date
**Date:** 2020-10-17

**Type:** ACTUAL

**Status Verified Date:** 2022-09

#### Study First Post Date
**Date:** 2020-10-22
**Type:** ACTUAL
**Study First Submit Date:** 2020-10-16
**Study First Submit QC Date:** 2020-10-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Lead Sponsor

**Class:** OTHER

**Name:** H. Lee Moffitt Cancer Center and Research Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Coronavirus Infection

**Keywords:**

- COVID -19

- SARC-CoV-2

### Design Module

#### Design Info

**Observational Model:** ECOLOGIC_OR_COMMUNITY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1135

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Diagnostic Test: SARS-CoV-2 Antibody Analysis

- Diagnostic Test: Weck-cel Swab Collection

- Behavioral: Web Based Questionnaire

**Label:** Participants age 18-34

#### Arm Group 2

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

**Intervention Names:**

- Diagnostic Test: SARS-CoV-2 Antibody Analysis

- Diagnostic Test: Weck-cel Swab Collection

- Behavioral: Web Based Questionnaire

**Label:** Participants age 35-54

#### Arm Group 3

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

**Intervention Names:**

- Diagnostic Test: SARS-CoV-2 Antibody Analysis

- Diagnostic Test: Weck-cel Swab Collection

- Behavioral: Web Based Questionnaire

**Label:** Participants age 55-64

#### Arm Group 4

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

**Intervention Names:**

- Diagnostic Test: SARS-CoV-2 Antibody Analysis

- Diagnostic Test: Weck-cel Swab Collection

- Behavioral: Web Based Questionnaire

**Label:** Participants 65 and over

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Participants 65 and over

- Participants age 18-34

- Participants age 35-54

- Participants age 55-64

**Description:** 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.

**Name:** SARS-CoV-2 Antibody Analysis

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Participants 65 and over

- Participants age 18-34

- Participants age 35-54

- Participants age 55-64

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

**Name:** Weck-cel Swab Collection

**Type:** DIAGNOSTIC_TEST

#### Intervention 3

**Arm Group Labels:**

- Participants 65 and over

- Participants age 18-34

- Participants age 35-54

- Participants age 55-64

**Description:** 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.

**Name:** Web Based Questionnaire

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** All participants who respond to study invitation letter will be tested for SARS-CoV-2 antibodies after completing a web-based questionnaire.

**Measure:** Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit

**Time Frame:** At study start

**Description:** 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.

**Measure:** Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit

**Time Frame:** At 4 weeks

**Description:** 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.

**Measure:** Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit

**Time Frame:** At 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Community Sample

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tampa

**Country:** United States

**Facility:** Moffitt Cancer Center

**State:** Florida

**Zip:** 33612

#### Overall Officials

**Official 1:**

**Affiliation:** Moffitt Cancer Center

**Name:** Anna R Giuliano, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### See Also Links

**Label:** Moffitt Cancer Center's Clinical Trials Website

**URL:** https://moffitt.org/clinical-trials-research/clinical-trials

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: HIGH

- As Found: Coronavirus Infection

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018352

- Term: Coronavirus Infections

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Program

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000906

- Term: Antibodies

### Misc Info Module

- Version Holder: 2024-05-24
