COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses (SEROBL-COVID19)

November 21, 2022 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

477

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Liestal, Switzerland, 4410
        • Department of Health, Economics and Health Directorate Canton Basel-Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants will be selected from the database of all positive PCR cases for COVID-19 tested in the canton Basel-Land.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • continuous steroid therapy / chemotherapy / immunsuppressiva
  • subject is treated for cancer
  • severe autoimmune disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: 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)
Diagnostic test: fingertip tests for POC assays
performing POC test by taking two blood drops from the fingertip
Diagnostic test: 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.
Diagnostic test: 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)
Diagnostic test: fingertip tests for POC assays
performing POC test by taking two blood drops from the fingertip
Diagnostic test: 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.
Diagnostic test: 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)
Diagnostic test: fingertip tests for POC assays
performing POC test by taking two blood drops from the fingertip
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline
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.
at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune cell repertoire sequencing
Time Frame: at baseline
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.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

ETH Zurich (Switzerland)
Health Department of the Canton of Basel-Stadt

Investigators

  • Principal Investigator: Miodrag Savic, Dr. med., Department of Health, Economics and Health Directorate Canton Basel-Land

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2020

Primary Completion (Actual)

May 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 21, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC Project-ID 2020-00816

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The Biobank data is planned to be shared according to the Biobank regulatory approved by the EKNZ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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