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

Completed

• Conditions: COVID-19 Infection

• Registration Number: NCT04483908
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

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 Timeline

• Study Start: 2020-04-10
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-23
• Primary Completion: 2021-05-30
• Study Completion: 2021-12-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Qualitative method validation (yes/ no)	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)	at baseline	Quantitative method validation: antibody concentration from the ELISA are related to the dichotomous result from POC.

Secondary Outcome Measures

Name	Time	Method
Immune cell repertoire sequencing	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.

Trial Locations

Locations (1)

Department of Health, Economics and Health Directorate Canton Basel-Land; 🇨🇭 Liestal, Switzerland