Clinical trial NCT04483908: COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Infection
Keywords: Sars-CoV-2 infection
ELISA test
lateral flow assay
point of care (POC) assay
saliva based serology
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: ETH Zurich (Switzerland)
name: Health Department of the Canton of Basel-Stadt
First posted: 2020-07-23
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be selected from the database of all positive PCR cases for COVID-19 tested in the canton Basel-Land.

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

Eligibility criteria: 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

Primary outcomes:
measure: Qualitative method validation (yes/ no)
timeFrame: at baseline
measure: Quantitative method validation (antibody concentrations)
timeFrame: at baseline
Secondary outcomes:
measure: Immune cell repertoire sequencing
timeFrame: at baseline
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Department of Health, Economics and Health Directorate Canton Basel-Land
Study officials:
affiliation: Department of Health, Economics and Health Directorate Canton Basel-Land
name: Miodrag Savic, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: