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

Coronavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596579
• Other study ID #: MCC-20635
• Status: Completed
• Start date: October 17, 2020
• Est. completion date: July 25, 2021

Study information

• Verified date: September 2022
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1135
• Est. completion date: July 25, 2021
• Est. primary completion date: July 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections

Intervention

Diagnostic Test:
• 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.
• Weck-cel Swab Collection
A Weck-cel swab will be used to collect secretions from the mucosal epithelium

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   Moffitt Cancer Center's Clinical Trials Website