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

COVID-19 Infection Clinical Trial

— SEROBL-COVID19  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483908
• Other study ID #: BASEC Project-ID 2020-00816
• Status: Completed
• Start date: April 10, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: December 31, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection

Intervention

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)
• 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)

Locations

Country	Name	City	State
Switzerland	Department of Health, Economics and Health Directorate Canton Basel-Land	Liestal

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	ETH Zurich (Switzerland), Health Department of the Canton of Basel-Stadt

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at baseline
Primary	Quantitative method validation (antibody concentrations)	Quantitative method validation: antibody concentration from the ELISA are related to the dichotomous result from POC.	at baseline
Secondary	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.	at baseline