Coronavirus InfectionNCT04596579
SARS-CoV-2 (COVID-19) Immune Surveillance Among a Population Based Sample of Adults in Florida
An observational study of Coronavirus Infection, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- SARS-CoV-2 Antibody Analysis, Weck-cel Swab Collection and Web Based Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,135 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2020to 25 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community Sample
Who may be able to join
- Resident of Hillsborough County, Florida
- 18 years of age or older
- Currently not exhibiting symptoms of SARS-CoV-2 infection
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS-CoV-2 Immune Surveillance Among a Population Based Sample of Adults in Florida
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
- Coronavirus Infection
- Being tested
- SARS-CoV-2 Antibody Analysis, Weck-cel Swab Collection, Web Based Questionnaire
- Keywords
- COVID -19, SARC-CoV-2
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 Antibody AnalysisDiagnostic test
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 CollectionDiagnostic test
A Weck-cel swab will be used to collect secretions from the mucosal epithelium
Web Based QuestionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants age 18-34 | Up to 300 participants age 18-34 who received an invitation by mail and are free of fever at time of interview. Receives: Diagnostic Test: SARS-CoV-2 Antibody Analysis; Diagnostic Test: Weck-cel Swab Collection; Behavioral: Web Based Questionnaire | |
| Participants age 35-54 | Up to 300 Participants age 35-54 who received an invitation by mail and are free of fever at time of interview. Receives: Diagnostic Test: SARS-CoV-2 Antibody Analysis; Diagnostic Test: Weck-cel Swab Collection; Behavioral: Web Based Questionnaire | |
| Participants age 55-64 | Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview. Receives: Diagnostic Test: SARS-CoV-2 Antibody Analysis; Diagnostic Test: Weck-cel Swab Collection; Behavioral: Web Based Questionnaire | |
| Participants 65 and over | Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview. Receives: Diagnostic Test: SARS-CoV-2 Antibody Analysis; Diagnostic Test: Weck-cel Swab Collection; Behavioral: Web Based Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start17 Oct 2020
- Primary completion25 Jul 2021
- Study completion25 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,135 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Anna R Giuliano, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596579
- Sponsor's protocol ID
- MCC-20635
- Status last verified
- Sep 2022
- First submitted
- 16 Oct 2020
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Immune Surveillance Among a Population Based Sample of Adults in Florida
- ClinicalTrials.gov ID
- NCT04596579
- Acronym / sponsor ID
- MCC-20635
- Conditions
- Coronavirus Infection
- Keywords
- COVID -19, SARC-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,135 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 25 Jul 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants age 18-34 | – | Diagnostic Test: SARS-CoV-2 Antibody Analysis, Diagnostic Test: Weck-cel Swab Collection, Behavioral: Web Based QuestionnaireUp to 300 participants age 18-34 who received an invitation by mail and are free of fever at time of interview. |
| Participants age 35-54 | – | Diagnostic Test: SARS-CoV-2 Antibody Analysis, Diagnostic Test: Weck-cel Swab Collection, Behavioral: Web Based QuestionnaireUp to 300 Participants age 35-54 who received an invitation by mail and are free of fever at time of interview. |
| Participants age 55-64 | – | Diagnostic Test: SARS-CoV-2 Antibody Analysis, Diagnostic Test: Weck-cel Swab Collection, Behavioral: Web Based QuestionnaireUp to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview. |
| Participants 65 and over | – | Diagnostic Test: SARS-CoV-2 Antibody Analysis, Diagnostic Test: Weck-cel Swab Collection, Behavioral: Web Based QuestionnaireUp to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (3 listed)
- Resident of Hillsborough County, Florida
- 18 years of age or older
- Currently not exhibiting symptoms of SARS-CoV-2 infection
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 Antibody Analysis10 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. | Diagnostic test | Participants 65 and over, Participants age 18-34, Participants age 35-54, Participants age 55-64 |
| Weck-cel Swab CollectionA Weck-cel swab will be used to collect secretions from the mucosal epithelium | Diagnostic test | Participants 65 and over, Participants age 18-34, Participants age 35-54, Participants age 55-64 |
| Web Based QuestionnaireA 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. | Behavioural | Participants 65 and over, Participants age 18-34, Participants age 35-54, Participants age 55-64 |
Primary outcome
Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit
Time frame: At study start
All participants who respond to study invitation letter will be tested for SARS-CoV-2 antibodies after completing a web-based questionnaire.
Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit
Time frame: At 4 weeks
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.
Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit
Time frame: At 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna R Giuliano, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit (time frame: At study start). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.