History of Covid-19, SeroprevalenceCovidImmunEyeNCT04446338
Immune Status SARS-CoV-2 in a Sample of a Tertiary Eye Health Centre
An observational study of History of Covid-19, Seroprevalence, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
A sequential combination of different antibodies test against SARS-CoV-2 is evaluated. The protocol included a rapid test and several ELISA tests within a defined cohort of healthcare workers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- History of Covid-19, Seroprevalence
- What is being tested?
- Antibody Test
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 13 May 2020to Aug 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Employee of the Department of Ophthalmology (at a university institution)
Who may be able to join
- Employees of the health facility described
- voluntary request for testing
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Focke Ziemssen, +49 7071 29 88088, focke.ziemssen@med.uni-tuebingen.de
Focke Ziemssen, MD
About this study
Official title: Immune Status: Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Sample of the Eye Department (University Eye Hospital and Research Institute Tübingen)
A sequential combination of different antibodies test against SARS-CoV-2 is evaluated. The protocol included a rapid test and several ELISA tests within a defined cohort of healthcare workers.
Read the detailed description
In the current pandemic, the assessment of actual COVID-19 infections plays an important role in the assessment of the risk and progress of the epidemic. Shortly, more and more rapid tests will be available, the aim of which is to be able to obtain a good overview of the immune status of corresponding samples in a timely manner.
Employees in the health sector are faced with additional challenges, not only due to the tightened hygiene regulations. The concern about infecting other people and/or exposing oneself to a relevant health risk is of great importance. A moderate to high transmission risk can be assumed for ophthalmology. In view of older patients and sometimes unavoidable proximity, targeted and reliable diagnostics can offer the potential to reduce the risk potential for the current situation by determining antibodies.
A rapid diagnosis is not yet available outside of clinical studies, especially since deficits in specificity (contact with other coronaviruses) are to be expected. Studies on the serological reaction are not yet available for longer observation periods, but it can be assumed that positive direct detection of IgG (Anti Sars-CV-2-ELISA; Euroimmun) is available at the latest 3 weeks after the onset of symptoms. Without larger and representative analyses, it is currently unclear whether seroconversion is associated with permanent immunity or a lack of it leads to a possible susceptibility to reinfection. A combined test procedure is therefore to be offered to employees within the framework of a random sample.
The query of anamnestic parameters allows the assignment to different groups (CC: past COVID infection, PC: possible infection, N: asymptomatic). The primary goal of the planned study is to provide a first preliminary evaluation of the tests used in the current context.
- Conditions
- History of Covid-19, Seroprevalence
- Being tested
- Antibody Test
- Keywords
- Seroprevalence, Covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibody TestDiagnostic test
Presence and Titer of Anti-Sars-CoV-2 Antbodies
| Study group | Role | What they receive |
|---|---|---|
| Healthcare Worker | Staff of the Department of Ophthalmology, University Tuebingen, Germany Receives: Diagnostic Test: Antibody Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevalence
Rate of anti-SARS-CoV-2 Antibodies
Measured: through study completion, maximum of one year
Secondary outcomes (2)
Agreement of the test results and questionnaire
Kappa statistics
Measured: through study completion, maximum of one year
Positive predictive / negative values of the tests applied
Measured: through study completion, maximum of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start13 May 2020
- Primary completion30 Jun 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for History of Covid-19, SeroprevalenceStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446338
- Sponsor's protocol ID
- 292/2020BO2
- Acronym
- CovidImmunEye
- Status last verified
- May 2020
- First submitted
- 22 Jun 2020
- Last updated
- 24 Jun 2020
- 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 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Status: Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Sample of the Eye Department (University Eye Hospital and Research Institute Tübingen)
- ClinicalTrials.gov ID
- NCT04446338
- Acronym / sponsor ID
- CovidImmunEye / 292/2020BO2
- Conditions
- History of Covid-19, Seroprevalence
- Keywords
- Seroprevalence, Covid-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Institute of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine
- Study start
- 13 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 24 Jun 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.
A sequential combination of different antibodies test against SARS-CoV-2 is evaluated. The protocol included a rapid test and several ELISA tests within a defined cohort of healthcare workers.
Detailed description
In the current pandemic, the assessment of actual COVID-19 infections plays an important role in the assessment of the risk and progress of the epidemic. Shortly, more and more rapid tests will be available, the aim of which is to be able to obtain a good overview of the immune status of corresponding samples in a timely manner.
Employees in the health sector are faced with additional challenges, not only due to the tightened hygiene regulations. The concern about infecting other people and/or exposing oneself to a relevant health risk is of great importance. A moderate to high transmission risk can be assumed for ophthalmology. In view of older patients and sometimes unavoidable proximity, targeted and reliable diagnostics can offer the potential to reduce the risk potential for the current situation by determining antibodies.
A rapid diagnosis is not yet available outside of clinical studies, especially since deficits in specificity (contact with other coronaviruses) are to be expected. Studies on the serological reaction are not yet available for longer observation periods, but it can be assumed that positive direct detection of IgG (Anti Sars-CV-2-ELISA; Euroimmun) is available at the latest 3 weeks after the onset of symptoms. Without larger and representative analyses, it is currently unclear whether seroconversion is associated with permanent immunity or a lack of it leads to a possible susceptibility to reinfection. A combined test procedure is therefore to be offered to employees within the framework of a random sample.
The query of anamnestic parameters allows the assignment to different groups (CC: past COVID infection, PC: possible infection, N: asymptomatic). The primary goal of the planned study is to provide a first preliminary evaluation of the tests used in the current context.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare Worker | – | Diagnostic Test: Antibody TestStaff of the Department of Ophthalmology, University Tuebingen, Germany |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Employee of the Department of Ophthalmology (at a university institution)
Key inclusion criteria (2 listed)
- Employees of the health facility described
- voluntary request for testing
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Antibody TestPresence and Titer of Anti-Sars-CoV-2 Antbodies | Diagnostic test | Healthcare Worker |
Primary outcome
Seroprevalence
Time frame: through study completion, maximum of one year
Rate of anti-SARS-CoV-2 Antibodies
2 secondary outcomes
Agreement of the test results and questionnaire
Time frame: through study completion, maximum of one year
Positive predictive / negative values of the tests applied
Time frame: through study completion, maximum of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: No
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.
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 History of Covid-19, Seroprevalence, run by University Hospital Tuebingen at 1 site in Germany.
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 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 24 Jun 2020. 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 Germany. 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?
Contact Focke Ziemssen, MD (+49 7071 29 88088, focke.ziemssen@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprevalence (time frame: through study completion, maximum of one year). 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 24 Jun 2020.