COVID-19 InfectionSEROBL-COVID19NCT04483908
COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses
An observational study of COVID-19 Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The study is to investigate the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- blood draw, fingertip tests for POC assays and saliva collection
- How many people
- 477 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Apr 2020to 31 Dec 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: Study participants will be selected from the database of all positive PCR cases for COVID-19 tested in the canton Basel-Land.
Who may be able to join
- tested positive for COVID-19 in Baselland
- tested negative for COVID-19 in Baselland. Specifically, needed to show symptoms to be able to deduce cross reactivities.
Who cannot join
- continuous steroid therapy / chemotherapy / immunsuppressiva
- subject is treated for cancer
- severe autoimmune disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Health, Economics and Health Directorate Canton Basel-Land
Liestal, 4410
About this study
Official title: COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses (SERO-BL-COVID-19)
The study is to investigate the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.
Read the detailed description
This study is to analyse the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.
The study aims to validate strategies to measure antibody levels with minimal intervention and to explore the antibody response and technical capacity for said measurement. The study will collect the minimally necessary samples to deduce a strategy for serum or saliva surveillance of the population of the canton Baselland. To achieve this, the study is designed to address the following points:
- determine specificity, sensitivity and general utility of point of care (POC) and ELISA tests to deduce a strategy for serum surveillance of the population of the canton Baselland
- especially validate different POC kits in regard of their use for continuous surveillance
- gain an understanding of seroconversion and antibody levels of patients and survivors
- gain an understanding of the individual antibody and T-cell repertoire of patients and survivors
- study whether patterns of convergent antibody evolution is generated in the surviving population or whether the diseases survivors generated an antibody pool recognizing a specific epitope
- develop the technology to correlate blood antibody levels with levels detected in the saliva
- develop high throughput technologies for the precise detection of immune cell Repertoire and binding epitopes
- Conditions
- COVID-19 Infection
- Being tested
- blood draw, fingertip tests for POC assays, saliva collection, collection of swabs
- Keywords
- Sars-CoV-2 infection, ELISA test, lateral flow assay, point of care (POC) assay, saliva based serology
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawDiagnostic test
2x 10ml of blood, one vial to obtain the antibodies and one vial in ethylenediaminetetraacetic acid (EDTA) (or citrate-treated) to obtain peripheral blood mononuclear cells (PBMCs)
fingertip tests for POC assaysDiagnostic test
performing POC test by taking two blood drops from the fingertip
saliva collectionDiagnostic test
saliva collection: the patient delivers saliva into an adsorbent filter, which is placed in the Salivette tube, centrifuged at 1,600x g for 15 min at 4°C to remove cells and debris. Native supernatant is used for testing.
collection of swabsDiagnostic test
collection of nasopharyngeal and oropharyngeal swabs for PCR testing on the control group (eg negative subpopulation)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Disease survivors with a positive polymerase chain reaction (PCR) test > 12days (d) ago and no symptoms (~250 participants).
Cohort 1 \& 2 are supposed to have an antibody response to different levels and should provide ability to deduce the detection limit, and estimate the true positive and false negative rates of both ELISA and POC assays. Receives: Diagnostic Test: blood draw; Diagnostic Test: fingertip tests for POC assays; Diagnostic Test: saliva collection | |
| Cohort 2 | Disease survivors with a positive PCR test 7 - 12d ago and no symptoms (~100 participants).
Cohort 1 \& 2 are supposed to have an antibody response to different levels and should provide ability to deduce the detection limit, and estimate the true positive and false negative rates of both ELISA and POC assays. Receives: Diagnostic Test: blood draw; Diagnostic Test: fingertip tests for POC assays; Diagnostic Test: saliva collection | |
| Cohort 3 | Subjects with PCR negative test > 5d (~100 participants). Cohort 3 \& 4 are the control groups. They are supposed to not have an antibody response for COVID-19 and should therefore help estimate the true negative and false positive rates. Receives: Diagnostic Test: blood draw; Diagnostic Test: fingertip tests for POC assays; Diagnostic Test: saliva collection; Diagnostic Test: collection of swabs | |
| Cohort 4 | Anonymised blood sera from the "Serumbank" at the Kantonsspital Basel-Land (KSBL) taken during last years influenza period (~100 participants).
Cohort 3 \& 4 are the control groups. They are supposed to not have an antibody response for COVID-19 and should therefore help estimate the true negative and false positive rates. Receives: Diagnostic Test: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative method validation (yes/ no)
Qualitative method validation: qualitative result of the ELISA (Patient does / does not have immunity) as the gold standard compared to the POC using univariate measures to derive sensitivity and specificity of the POC.
Measured: at baseline
Quantitative method validation (antibody concentrations)
Quantitative method validation: antibody concentration from the ELISA are related to the dichotomous result from POC.
Measured: at baseline
Secondary outcomes (1)
Immune cell repertoire sequencing
Antibody and T cell repertoires and transcriptional profiles of cells will be used to identify potential antibody and T cell clones correlated with COVID-19 protection.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start10 Apr 2020
- Primary completion30 May 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich (Switzerland), Health Department of the Canton of Basel-Stadt
- Responsible party
- Sponsor
- Investigators
- Miodrag Savic, Dr. med., Principal investigator, Department of Health, Economics and Health Directorate Canton Basel-Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483908
- Sponsor's protocol ID
- BASEC Project-ID 2020-00816
- Acronym
- SEROBL-COVID19
- Status last verified
- Nov 2022
- First submitted
- 22 Jul 2020
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Biobank data is planned to be shared according to the Biobank regulatory approved by the EKNZ
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses (SERO-BL-COVID-19)
- ClinicalTrials.gov ID
- NCT04483908
- Acronym / sponsor ID
- SEROBL-COVID19 / BASEC Project-ID 2020-00816
- Conditions
- COVID-19 Infection
- Keywords
- Sars-CoV-2 infection, ELISA test, lateral flow assay, point of care (POC) assay, saliva based serology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- ETH Zurich (Switzerland), Health Department of the Canton of Basel-Stadt
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Jul 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 study is to investigate the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.
Detailed description
This study is to analyse the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.
The study aims to validate strategies to measure antibody levels with minimal intervention and to explore the antibody response and technical capacity for said measurement. The study will collect the minimally necessary samples to deduce a strategy for serum or saliva surveillance of the population of the canton Baselland. To achieve this, the study is designed to address the following points:
- determine specificity, sensitivity and general utility of point of care (POC) and ELISA tests to deduce a strategy for serum surveillance of the population of the canton Baselland
- especially validate different POC kits in regard of their use for continuous surveillance
- gain an understanding of seroconversion and antibody levels of patients and survivors
- gain an understanding of the individual antibody and T-cell repertoire of patients and survivors
- study whether patterns of convergent antibody evolution is generated in the surviving population or whether the diseases survivors generated an antibody pool recognizing a specific epitope
- develop the technology to correlate blood antibody levels with levels detected in the saliva
- develop high throughput technologies for the precise detection of immune cell Repertoire and binding epitopes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: blood draw, Diagnostic Test: fingertip tests for POC assays, Diagnostic Test: saliva collectionDisease survivors with a positive polymerase chain reaction (PCR) test > 12days (d) ago and no symptoms (~250 participants). Cohort 1 \& 2 are supposed to have an antibody response to different levels and should provide ability to deduce the detection limit, and estimate the true positive and false negative rates of both ELISA and POC assays. |
| Cohort 2 | – | Diagnostic Test: blood draw, Diagnostic Test: fingertip tests for POC assays, Diagnostic Test: saliva collectionDisease survivors with a positive PCR test 7 - 12d ago and no symptoms (~100 participants). Cohort 1 \& 2 are supposed to have an antibody response to different levels and should provide ability to deduce the detection limit, and estimate the true positive and false negative rates of both ELISA and POC assays. |
| Cohort 3 | – | Diagnostic Test: blood draw, Diagnostic Test: fingertip tests for POC assays, Diagnostic Test: saliva collection, Diagnostic Test: collection of swabsSubjects with PCR negative test > 5d (~100 participants). Cohort 3 \& 4 are the control groups. They are supposed to not have an antibody response for COVID-19 and should therefore help estimate the true negative and false positive rates. |
| Cohort 4 | – | Diagnostic Test: blood drawAnonymised blood sera from the "Serumbank" at the Kantonsspital Basel-Land (KSBL) taken during last years influenza period (~100 participants). Cohort 3 \& 4 are the control groups. They are supposed to not have an antibody response for COVID-19 and should therefore help estimate the true negative and false positive rates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from the database of all positive PCR cases for COVID-19 tested in the canton Basel-Land.
Key inclusion criteria (2 listed)
- tested positive for COVID-19 in Baselland
- tested negative for COVID-19 in Baselland. Specifically, needed to show symptoms to be able to deduce cross reactivities.
Key exclusion criteria (3 listed)
- continuous steroid therapy / chemotherapy / immunsuppressiva
- subject is treated for cancer
- severe autoimmune disease
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 |
|---|---|---|
| blood draw2x 10ml of blood, one vial to obtain the antibodies and one vial in ethylenediaminetetraacetic acid (EDTA) (or citrate-treated) to obtain peripheral blood mononuclear cells (PBMCs) | Diagnostic test | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| fingertip tests for POC assaysperforming POC test by taking two blood drops from the fingertip | Diagnostic test | Cohort 1, Cohort 2, Cohort 3 |
| saliva collectionsaliva collection: the patient delivers saliva into an adsorbent filter, which is placed in the Salivette tube, centrifuged at 1,600x g for 15 min at 4°C to remove cells and debris. Native supernatant is used for testing. | Diagnostic test | Cohort 1, Cohort 2, Cohort 3 |
| collection of swabscollection of nasopharyngeal and oropharyngeal swabs for PCR testing on the control group (eg negative subpopulation) | Diagnostic test | Cohort 3 |
Primary outcome
Qualitative method validation (yes/ no)
Time frame: at baseline
Qualitative method validation: qualitative result of the ELISA (Patient does / does not have immunity) as the gold standard compared to the POC using univariate measures to derive sensitivity and specificity of the POC.
Quantitative method validation (antibody concentrations)
Time frame: at baseline
Quantitative method validation: antibody concentration from the ELISA are related to the dichotomous result from POC.
1 secondary outcome
Immune cell repertoire sequencing
Time frame: at baseline
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 22 Nov 2022.
- Individual participant dataSharing planned: Undecided. The Biobank data is planned to be shared according to the Biobank regulatory approved by the EKNZ
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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.
Miodrag Savic, Dr. med. principal investigator
Department of Health, Economics and Health Directorate Canton Basel-Land
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 COVID-19 Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 22 Nov 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 Switzerland. 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?
Qualitative method validation (yes/ no) (time frame: at baseline). The study lists 2 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 22 Nov 2022.