COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses
SEROBL-COVID19
1 other identifier
observational
477
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2020
CompletedFirst Submitted
Initial submission to the registry
July 22, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedNovember 22, 2022
November 1, 2022
1.1 years
July 22, 2020
November 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Quantitative method validation (antibody concentrations)
Quantitative method validation: antibody concentration from the ELISA are related to the dichotomous result from POC.
at baseline
Secondary Outcomes (1)
Immune cell repertoire sequencing
at baseline
Study Arms (4)
Cohort 1
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.
Cohort 2
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.
Cohort 3
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.
Cohort 4
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.
Interventions
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)
performing POC test by taking two blood drops from the fingertip
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 nasopharyngeal and oropharyngeal swabs for PCR testing on the control group (eg negative subpopulation)
Eligibility Criteria
Study participants will be selected from the database of all positive PCR cases for COVID-19 tested in the canton Basel-Land.
You may qualify if:
- 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.
You may not qualify if:
- continuous steroid therapy / chemotherapy / immunsuppressiva
- subject is treated for cancer
- severe autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Basel, Switzerlandlead
- ETH Zurich (Switzerland)collaborator
- Health Department of the Canton of Basel-Stadtcollaborator
Study Sites (1)
Department of Health, Economics and Health Directorate Canton Basel-Land
Liestal, 4410, Switzerland
Biospecimen
Immune cells (B cells and T cells) from peripheral blood mononuclear cells (PBMC) from the cohort of COVID-19 recovered patients will be subjected to bulk and single-cell RNA sequencing (RNA-seq). Biological material in this project is not identified by participant name but by a unique participant number. Biological material is appropriately stored in a restricted area only accessible to authorized personnel. Biobank is handled by the accredited diagnostic lab of the Swiss TPH according to the rules of clinical sample storage.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miodrag Savic, Dr. med.
Department of Health, Economics and Health Directorate Canton Basel-Land
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2020
First Posted
July 23, 2020
Study Start
April 10, 2020
Primary Completion
May 30, 2021
Study Completion
December 31, 2021
Last Updated
November 22, 2022
Record last verified: 2022-11