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Completed

NCT Number: NCT04483908

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Health, Economics and Health Directorate Canton Basel-Land

Liestal, 4410, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw

Diagnostic 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 assays

Diagnostic Test

performing POC test by taking two blood drops from the fingertip

saliva collection

Diagnostic 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 swabs

Diagnostic Test

collection of nasopharyngeal and oropharyngeal swabs for PCR testing on the control group (eg negative subpopulation)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

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

Registry information

Official study 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)

Acronym: SEROBL-COVID19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2020
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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