Covid19PCFRNCT04682132
Polk COVID-19 and Flu Response
An observational study of Covid19, run by Polk County Fire Rescue at 1 site in United States.
Trial summary
Study Objectives: To perform COVID-19 diagnostic and serologic testing on emergency medical personnel in Polk County to determine: 1. COVID-19 prevalence 2. Rate of convalesced personnel (+antibodies) 3. Rate of asymptomatic carriers Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- COVID-19 antigen and antibody tests, and influenza rapid test
- How many people
- 686 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2020to 31 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: Volunteers of Polk County (FL) emergency personnel
Who may be able to join
- Polk County (FL) emergency personnel including EMS, Fire Rescue, Board of County Commissioners, and Sheriff's office
Who cannot join
- Age < 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: County-wide Emergency Personnel Assessment of COVID-19 and Influenza Status
Study Objectives:
To perform COVID-19 diagnostic and serologic testing on emergency medical personnel in Polk County to determine:
- COVID-19 prevalence
- Rate of convalesced personnel (+antibodies)
- Rate of asymptomatic carriers
Read the detailed description
This observational study involves a community wide program offering free COVID-19 testing to county front line workers, including EMS personnel, board of county commissioners and sheriffs' office personnel. These personnel will also be asked to fill out a survey that asks about their medical history and which of any symptoms they have experienced in the prior three weeks. The survey is voluntary and written informed consent is obtained . EMS personnel can still get the free testing even if they do not want to fill out the survey.
The primary objective of the study is to describe the prevalence of COVID-19 antigen and IgM and IgG markers amongst our county/EMS workers.
The secondary objective is to describe whether the antigen/antibody markers are significantly correlated to the presence of a set of symptoms in the prior 3 weeks, and/or to the baseline demographics such as age, sex, and presence of co-morbidities.
- Conditions
- Covid19
- Being tested
- COVID-19 antigen and antibody tests, and influenza rapid test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 antigen and antibody tests, and influenza rapid testDiagnostic test
Study volunteers will be offered free COVID-19 and influenza testing and the opportunity to complete an electronic survey about any symptoms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of COVID-19 amongst county emergency personnel
To assess the prevalence of COVID-19 amongst county emergency personnel
Measured: May-December 2020
Secondary outcomes (2)
Correlation of common COVID-19 symptoms with result of COVID-19 test
To correlate common COVID-19 symptoms with result of COVID-19 test
Measured: May-December 2020
Co-existence of influenza and COVID-19 positive test results
Co-existence of influenza and COVID-19 positive test results with or without symptoms
Measured: May-December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start26 May 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polk County Fire Rescue
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Campion, Breanna <breannacampion@polk-county.net> Campion, Study director, Polk County Fire Rescue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682132
- Sponsor's protocol ID
- 00001784
- Acronym
- PCFR
- Status last verified
- Apr 2021
- First submitted
- 22 Dec 2020
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- County-wide Emergency Personnel Assessment of COVID-19 and Influenza Status
- ClinicalTrials.gov ID
- NCT04682132
- Acronym / sponsor ID
- PCFR / 00001784
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 686 participants (actual)
- Lead sponsor
- Polk County Fire RescueOther government
- Study start
- 26 May 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 23 Dec 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.
Study Objectives:
To perform COVID-19 diagnostic and serologic testing on emergency medical personnel in Polk County to determine:
- COVID-19 prevalence
- Rate of convalesced personnel (+antibodies)
- Rate of asymptomatic carriers
Detailed description
This observational study involves a community wide program offering free COVID-19 testing to county front line workers, including EMS personnel, board of county commissioners and sheriffs' office personnel. These personnel will also be asked to fill out a survey that asks about their medical history and which of any symptoms they have experienced in the prior three weeks. The survey is voluntary and written informed consent is obtained . EMS personnel can still get the free testing even if they do not want to fill out the survey.
The primary objective of the study is to describe the prevalence of COVID-19 antigen and IgM and IgG markers amongst our county/EMS workers.
The secondary objective is to describe whether the antigen/antibody markers are significantly correlated to the presence of a set of symptoms in the prior 3 weeks, and/or to the baseline demographics such as age, sex, and presence of co-morbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers of Polk County (FL) emergency personnel
Key inclusion criteria (1 listed)
- Polk County (FL) emergency personnel including EMS, Fire Rescue, Board of County Commissioners, and Sheriff's office
Key exclusion criteria (1 listed)
- Age < 18
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 |
|---|---|---|
| COVID-19 antigen and antibody tests, and influenza rapid testStudy volunteers will be offered free COVID-19 and influenza testing and the opportunity to complete an electronic survey about any symptoms. | Diagnostic test | – |
Primary outcome
Prevalence of COVID-19 amongst county emergency personnel
Time frame: May-December 2020
To assess the prevalence of COVID-19 amongst county emergency personnel
2 secondary outcomes
Correlation of common COVID-19 symptoms with result of COVID-19 test
Time frame: May-December 2020
Co-existence of influenza and COVID-19 positive test results
Time frame: May-December 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Campion, Breanna <breannacampion@polk-county.net> Campion study director
Polk County Fire Rescue
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 Covid19, run by Polk County Fire Rescue 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Apr 2021. 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?
Results are not available in the source record.
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?
Prevalence of COVID-19 amongst county emergency personnel (time frame: May-December 2020). 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 21 Apr 2021.