Covid19NCT04533360
Prevalence of COVID-19 Antibodies Kingman AZ
An observational study of Covid19, run by Kingman Regional Medical Center at 1 site in United States.
Trial summary
The COVID-19 disease outbreak is a historic event that has challenged medical systems in the United States. Currently, most reports of confirmed cases rely on the testing of symptomatic patients. 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?
- VITROS Anti-SARS-CoV-2 IgG test
- How many people
- 566 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 1 May 2021
- How long will I take part?
- 1 Month
- 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: ~30,000 individuals inhabit Kingman AZ across 7,854 households, out of which 30.1% had children under the age of 18 living with them, 54.6% were married couples living together, 10.1% had a female householder with no husband present, and 30.9% were non-families. 25.5% of all households were made up of individuals, and 11.7% had someone living alone who was 65 years of age or older.
Who may be able to join
- Adults aged 18+
- Resident of Mohave County AZ
Who cannot join
- Children under 18yo
- Previous positive SARS-CoV2- Antibody Test
- Active symptoms of respiratory Illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Kingman Regional Medical Center
Kingman, Arizona, 86409
About this study
Official title: Seroprevalence of SARS CoV2 Antibodies Among Adults in Kingman AZ
The COVID-19 disease outbreak is a historic event that has challenged medical systems in the United States. Currently, most reports of confirmed cases rely on the testing of symptomatic patients. These estimates of confirmed cases miss individuals who have recovered from infection, with mild or no symptoms, and individuals with symptoms who have not been tested due to the limited availability of tests. We are conducting serology testing within the community for SARS-CoV-2-specific antibodies through a serologic test could give insight into past COVID-19 infections within our community.
Read the detailed description
Adult participants aged 18 or greater will be recruited from the greater Kingman AZ area through social media, radio, newspaper, and a press release. Participants self-selected inclusion in the study by calling into a COVID-19 hotline and will be included in the sample data following self-report of absence of covid-19 symptoms. Participants will be scheduled for testing on the weeks of 09/28/2020 and 10/05/2020. Upon recruitment, participants will be asked to complete a demographic and behavioral survey, assessing socioeconomic status, interpersonal interactions, personal protective measures, and COVID-19 symptomology in the preceding two months. Two months after initial testing, all negative SARS-CoV-2-specific antibodies participants will be contacted for repeat testing and surveying.
SARS-CoV-2-specific antibodies will be tested using a lateral flow immunoassay with the VITROS Anti-SARS-CoV-2 IgG test (Ortho-Clinical Diagnostics, Inc.) under the Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). The diagnostic sensitivity of the immunoassay was 87.5% and specificity was 100%. The positive and negative predictive value with a prevalence of 5% in the community was 100% and 99.3% respectively. All data will be de-identified and stored in a password protected file only visible to study investigators. All positive results were called back to participants by the lead author.
Data obtained was then used to estimate the population prevalence of SARS-CoV-2-specific antibodies in the Kingman, Arizona population. Unweighted and weighted proportions of positive tests were calculated to match the 2018 census on sex, race, education, and income. Confidence intervals for unweighted data will be estimated using exact binomial models and for weighted and adjusted estimates using bootstrap methods. All data was analyzed using SPSS.
- Conditions
- Covid19
- Being tested
- VITROS Anti-SARS-CoV-2 IgG 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.
VITROS Anti-SARS-CoV-2 IgG testDiagnostic test
The VITROS Anti-SARS-CoV-2 IgG test is a lateral flow immunoassay produced by Ortho-Clinical Diagnostics Inc.
| Study group | Role | What they receive |
|---|---|---|
| Community Cohort 1 | 1000 Participants from the community will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 1. Receives: Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test | |
| Community Cohort 2 | 1000 Participants from the community will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 2. Receives: Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test | |
| Healthcare Provider Cohort 1 | 500 hospital employees will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 1. Receives: Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test | |
| Healthcare Provider Cohort 2 | 500 hospital employees will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 2. Receives: Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevelence of SARS-CoV-2 Antibodies among Adults in Kingman AZ
A sample from the population of Kingman AZ will be used to determine the epidemiology of COVID-19 spread throughout Kingman AZ.
Measured: 2-weeks
Secondary outcomes (1)
Retention of SARS-CoV-2 Antibodies among Adults in Kingman AZ
Participants will have a second antibody diagnostic test 2 months following initial enrollment. The concordance between positive tests will then be used to determine the longevity of SARS-CoV-2 antibodies in our community.
Measured: 2-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start28 Sep 2020
- Primary completion9 Oct 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 566 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Kingman Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Ashurst, Kingman Regional Medical Center
- Investigators
- Anthony J Santarelli, PhD, Study director, Kingman Healthcare Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533360
- Sponsor's protocol ID
- KRMC 0205
- Status last verified
- Mar 2022
- First submitted
- 28 Aug 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paul R, Arif AA, Adeyemi O, Ghosh S, Han D. Progression of COVID-19 From Urban to Rural Areas in the United States: A Spatiotemporal Analysis of Prevalence Rates. J Rural Health. 2020 Sep;36(4):591-601. doi: 10.1111/jrh.12486. Epub 2020 Jun 30.
PubMed 32602983Peters DJ. Community Susceptibility and Resiliency to COVID-19 Across the Rural-Urban Continuum in the United States. J Rural Health. 2020 Jun;36(3):446-456. doi: 10.1111/jrh.12477. Epub 2020 Jun 16.
PubMed 32543751Santarelli A, Lalitsasivimol D, Bartholomew N, Reid S, Reid J, Lyon C, Wells J, Ashurst J. The seroprevalence of SARS-CoV-2 in a rural southwest community. J Osteopath Med. 2021 Feb 1;121(2):199-210. doi: 10.1515/jom-2020-0287.
PubMed 33567087
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of SARS CoV2 Antibodies Among Adults in Kingman AZ
- ClinicalTrials.gov ID
- NCT04533360
- Acronym / sponsor ID
- KRMC 0205
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Kingman Regional Medical CenterUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 31 Aug 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 COVID-19 disease outbreak is a historic event that has challenged medical systems in the United States. Currently, most reports of confirmed cases rely on the testing of symptomatic patients. These estimates of confirmed cases miss individuals who have recovered from infection, with mild or no symptoms, and individuals with symptoms who have not been tested due to the limited availability of tests. We are conducting serology testing within the community for SARS-CoV-2-specific antibodies through a serologic test could give insight into past COVID-19 infections within our community.
Detailed description
Adult participants aged 18 or greater will be recruited from the greater Kingman AZ area through social media, radio, newspaper, and a press release. Participants self-selected inclusion in the study by calling into a COVID-19 hotline and will be included in the sample data following self-report of absence of covid-19 symptoms. Participants will be scheduled for testing on the weeks of 09/28/2020 and 10/05/2020. Upon recruitment, participants will be asked to complete a demographic and behavioral survey, assessing socioeconomic status, interpersonal interactions, personal protective measures, and COVID-19 symptomology in the preceding two months. Two months after initial testing, all negative SARS-CoV-2-specific antibodies participants will be contacted for repeat testing and surveying.
SARS-CoV-2-specific antibodies will be tested using a lateral flow immunoassay with the VITROS Anti-SARS-CoV-2 IgG test (Ortho-Clinical Diagnostics, Inc.) under the Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). The diagnostic sensitivity of the immunoassay was 87.5% and specificity was 100%. The positive and negative predictive value with a prevalence of 5% in the community was 100% and 99.3% respectively. All data will be de-identified and stored in a password protected file only visible to study investigators. All positive results were called back to participants by the lead author.
Data obtained was then used to estimate the population prevalence of SARS-CoV-2-specific antibodies in the Kingman, Arizona population. Unweighted and weighted proportions of positive tests were calculated to match the 2018 census on sex, race, education, and income. Confidence intervals for unweighted data will be estimated using exact binomial models and for weighted and adjusted estimates using bootstrap methods. All data was analyzed using SPSS.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Community Cohort 1 | – | Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test1000 Participants from the community will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 1. |
| Community Cohort 2 | – | Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test1000 Participants from the community will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 2. |
| Healthcare Provider Cohort 1 | – | Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test500 hospital employees will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 1. |
| Healthcare Provider Cohort 2 | – | Diagnostic Test: VITROS Anti-SARS-CoV-2 IgG test500 hospital employees will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ~30,000 individuals inhabit Kingman AZ across 7,854 households, out of which 30.1% had children under the age of 18 living with them, 54.6% were married couples living together, 10.1% had a female householder with no husband present, and 30.9% were non-families. 25.5% of all households were made up of individuals, and 11.7% had someone living alone who was 65 years of age or older.
Key inclusion criteria (2 listed)
- Adults aged 18+
- Resident of Mohave County AZ
Key exclusion criteria (3 listed)
- Children under 18yo
- Previous positive SARS-CoV2- Antibody Test
- Active symptoms of respiratory Illness
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 |
|---|---|---|
| VITROS Anti-SARS-CoV-2 IgG testThe VITROS Anti-SARS-CoV-2 IgG test is a lateral flow immunoassay produced by Ortho-Clinical Diagnostics Inc. | Diagnostic test | Community Cohort 1, Community Cohort 2, Healthcare Provider Cohort 1, Healthcare Provider Cohort 2 |
Primary outcome
Seroprevelence of SARS-CoV-2 Antibodies among Adults in Kingman AZ
Time frame: 2-weeks
A sample from the population of Kingman AZ will be used to determine the epidemiology of COVID-19 spread throughout Kingman AZ.
1 secondary outcome
Retention of SARS-CoV-2 Antibodies among Adults in Kingman AZ
Time frame: 2-weeks
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 31 Mar 2022.
- Background: PubMed 32602983Paul R, Arif AA, Adeyemi O, Ghosh S, Han D. Progression of COVID-19 From Urban to Rural Areas in the United States: A Spatiotemporal Analysis of Prevalence Rates. J Rural Health. 2020 Sep;36(4):591-601. doi: 10.1111/jrh.12486. Epub 2020 Jun 30.
- Background: PubMed 32543751Peters DJ. Community Susceptibility and Resiliency to COVID-19 Across the Rural-Urban Continuum in the United States. J Rural Health. 2020 Jun;36(3):446-456. doi: 10.1111/jrh.12477. Epub 2020 Jun 16.
- Derived from this study: PubMed 33567087Santarelli A, Lalitsasivimol D, Bartholomew N, Reid S, Reid J, Lyon C, Wells J, Ashurst J. The seroprevalence of SARS-CoV-2 in a rural southwest community. J Osteopath Med. 2021 Feb 1;121(2):199-210. doi: 10.1515/jom-2020-0287.
- 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.
Anthony J Santarelli, PhD study director
Kingman Healthcare Inc.
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 Kingman Regional Medical Center 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 2 inclusion and 3 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 31 Mar 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?
Seroprevelence of SARS-CoV-2 Antibodies among Adults in Kingman AZ (time frame: 2-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04533360, which also lists 3 linked publications.
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 31 Mar 2022.