SARS-CoV 2NCT04383587
Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers
A study testing Serologic testing in people with SARS-CoV 2 and COVID-19, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to identify healthcare workers with SARS CoV 2 antibodies who have not been previously diagnosed and are presumed COVID-19 negative, then determine the level of immunity in this population which could inform further decisions about widespread antibody testing in a healthcare worker… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV 2, COVID-19
- What is being tested?
- Serologic testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2020to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Age ≥ 18 years old.
- Mayo Clinic employee in procedural and surgical area.
- Suspected COVID-19 exposure.
- Completed PCR test twice with negative results.
Who cannot join
- Refusal to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to identify healthcare workers with SARS CoV 2 antibodies who have not been previously diagnosed and are presumed COVID-19 negative, then determine the level of immunity in this population which could inform further decisions about widespread antibody testing in a healthcare worker population.
Read the detailed description
Enrolled participants will complete a survey gauging their level of confidence they will be antibody positive. Participants will then complete serologic testing for SARS CoV 2 IgG antibodies. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between a pre-test confidence level using a Likert scale and actual antibody positivity.
- Conditions
- SARS-CoV 2, COVID-19
- Being tested
- Serologic testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serologic testingOther
COVID19 IgG antibody testing to be performed
| Study group | Role | What they receive |
|---|---|---|
| Serologic Arm | Other | Enrolled participants will have COVID19 IgG antibody testing performed. Receives: Other: Serologic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With COVID-19 Antibodies
Presence of IgG antibodies detected
Measured: 1 month
Secondary outcomes (1)
Ability to Predict Immune Status/Antibody Positivity
Survey of participants to gauge their confidence they will be antibody positive
Measured: Single point in time prior to COVID-19 Antibody testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start6 May 2020
- Primary completion1 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV 2Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark A. Parkulo, Mayo Clinic
- Investigators
- Mark Parkulo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383587
- Sponsor's protocol ID
- 20-004054
- Status last verified
- Apr 2022
- First submitted
- 7 May 2020
- Last updated
- 13 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers
- ClinicalTrials.gov ID
- NCT04383587
- Acronym / sponsor ID
- 20-004054
- Conditions
- SARS-CoV 2, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Posted 13 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify healthcare workers with SARS CoV 2 antibodies who have not been previously diagnosed and are presumed COVID-19 negative, then determine the level of immunity in this population which could inform further decisions about widespread antibody testing in a healthcare worker population.
Detailed description
Enrolled participants will complete a survey gauging their level of confidence they will be antibody positive. Participants will then complete serologic testing for SARS CoV 2 IgG antibodies. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between a pre-test confidence level using a Likert scale and actual antibody positivity.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serologic Arm | Other | Other: Serologic testingEnrolled participants will have COVID19 IgG antibody testing performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old.
- Mayo Clinic employee in procedural and surgical area.
- Suspected COVID-19 exposure.
- Completed PCR test twice with negative results.
Key exclusion criteria (1 listed)
- Refusal to participate in this study.
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 |
|---|---|---|
| Serologic testingCOVID19 IgG antibody testing to be performed | Other | Serologic Arm |
Primary outcome
Number of Participants With COVID-19 Antibodies
Time frame: 1 month
Presence of IgG antibodies detected
1 secondary outcome
Ability to Predict Immune Status/Antibody Positivity
Time frame: Single point in time prior to COVID-19 Antibody testing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Mark Parkulo, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serologic testing in people with SARS-CoV 2 and COVID-19, run by Mayo Clinic 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 4 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: finished, as of the sponsor's last update on 13 Apr 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?
Yes. Results are posted in the registry (first posted 13 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With COVID-19 Antibodies (time frame: 1 month). 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 13 Apr 2022.