SARS-CoV2 infection
Conditions
Interventions
No interventions
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet all of the following criteria: • Subject (male or female) tested positive for SARS-CoV2 by PCR (nasal swab, throat swab and/or sputum); • Subject is an adult of 18-65 years old; • Subject is able to understand the PIF document, written in Dutch; • Subject is able to communicate well with the investigator in the Dutch language; • Subject signed informed consent prior to any study-mandated procedure; • Subject is living in Leiden or direct environment (e.g. within 10 km from LUMC), allowing for traveling by car, bike or by walking to LUMC (no public transportation).
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Subject tested negative upon SARS-CoV2 PCR re-analysis of nasal swab at intake; • Subject previously fainted before, during or after a medical procedure with needles; • Subject received plasma or other blood products during the previous 3 months; • Subject received a vaccination during the previous 3 months; • Subject is obese with BMI =30, based on provide weight and length information; • Subject has a pre-existing coagulopathy; • Subject uses medication for a coagulopathy; • Subject uses medication that suppresses the immune system; • Subject has an auto-immune disease or another immune disease; • Subject has another infection in addition to the SARS-CoV2 infection; • Subject participated in a clinical trial within 6 months prior to this study; • For women: subject is pregnant or is providing breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dissection of the cellular and serological immune response against SARS-CoV2 with special attention for SARS-CoV2 specific T-cell & B-cell responses (including plasma cell and memory B-cell responses) and antibody formation against viral proteins as well as for innate inflammatory mediators. This includes the assessment of the primary (naïve) T-cell and B-cell repertoire as basis for the adaptive immune response against the new antigenic epitopes of SARS-CoV2 and the detailed mapping of innate and inflammatory mediators, fully in line with the analyses in patients of the BEAT-COVID-1 “sister” protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective 1: Single cell sequencing of immunoglobulin (IG) genes of SARS-CoV2-specific plasma cells and memory B-cells with special attention to anti-Spike antibodies and their capability to block viral binding to human ACE2 proteins. - Secondary objective 2: Cloning and expression of the selected IG genes for in-depth studies on antibody reactivity, particularly epitope mapping and affinity studies. - Secondary objective 3: Immune profiling of nasal mucosal immune responses. - Secondary objective 4: Single cell T-cell receptor (TR) gene sequencing of SARS-CoV2 specific CD4+ and CD8+ T-cells and characterization of dominant T-cell epitopes. - Secondary Objective 5: Sequencing of the viral Spike protein, being a major target of neutralizing antibodies, for mutant analysis, in relation to antibody responses (1). - Secondary objective 6: Assessment of activation of the coagulation system and complement system in parallel to the immune response. - Secondary objective 7: Sequencing of ACE2 and immune-related genes of the same individuals to understand the potential presence and meaning of polymorphisms. | — |
Contacts
Public ContactJacques J.M. van Dongen
LUMC
Outcome results
None listed