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

University Hospital Basel

Status: Completed

Conditions: COVID-19 Infection

Treatments: Diagnostic Test: fingertip tests for POC assays; Diagnostic Test: saliva collection; Diagnostic Test: collection of swabs; Diagnostic Test: blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT04483908

BASEC Project-ID 2020-00816

Details and patient eligibility

About

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.

Full 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

Enrollment: 477 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

477 participants in 4 patient groups

Cohort 1

Description:

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.

Treatment:

Diagnostic Test: saliva collection

Diagnostic Test: fingertip tests for POC assays

Diagnostic Test: blood draw

Cohort 2

Description:

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.

Treatment:

Diagnostic Test: saliva collection

Diagnostic Test: fingertip tests for POC assays

Diagnostic Test: blood draw

Cohort 3

Description:

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.

Treatment:

Diagnostic Test: saliva collection

Diagnostic Test: fingertip tests for POC assays

Diagnostic Test: collection of swabs

Diagnostic Test: blood draw

Cohort 4

Description:

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.

Treatment:

Diagnostic Test: blood draw