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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04596579
Other study ID # MCC-20635
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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