COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses
NCT ID: NCT04483908
Last Updated: 2022-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
477 participants
OBSERVATIONAL
2020-04-10
2021-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
blood draw
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 assays
performing POC test by taking two blood drops from the fingertip
saliva collection
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.
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.
blood draw
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 assays
performing POC test by taking two blood drops from the fingertip
saliva collection
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.
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.
blood draw
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 assays
performing POC test by taking two blood drops from the fingertip
saliva collection
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 swabs
collection of nasopharyngeal and oropharyngeal swabs for PCR testing on the control group (eg negative subpopulation)
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.
blood draw
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)
Interventions
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blood draw
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 assays
performing POC test by taking two blood drops from the fingertip
saliva collection
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 swabs
collection of nasopharyngeal and oropharyngeal swabs for PCR testing on the control group (eg negative subpopulation)
Eligibility Criteria
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Inclusion Criteria
* tested negative for COVID-19 in Baselland. Specifically, needed to show symptoms to be able to deduce cross reactivities.
Exclusion Criteria
* subject is treated for cancer
* severe autoimmune disease
18 Years
ALL
Yes
Sponsors
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ETH Zurich (Switzerland)
OTHER
Health Department of the Canton of Basel-Stadt
OTHER_GOV
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Miodrag Savic, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Health, Economics and Health Directorate Canton Basel-Land
Locations
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Department of Health, Economics and Health Directorate Canton Basel-Land
Liestal, , Switzerland
Countries
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Other Identifiers
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BASEC Project-ID 2020-00816
Identifier Type: -
Identifier Source: org_study_id
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