NCT04483908

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 477 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• COVID-19 Infection

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-04-10
• Primary completion: 2021-05-30
• Completion: 2021-12-31
• First posted: 2020-07-23
• Last updated: 2022-11-22

Locations

1 site across 1 country: Switzerland