Coronavirus Infection Clinical Trial
Official title:
SARS-CoV-2 Immune Surveillance Among a Population Based Sample of Adults in Florida
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 |
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Merck Sharp & Dohme LLC |
United States,
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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