Cellular and Serological Immune Response Monitoring in SARS-CoV2-infected individuals, without need of hospitalizatio
- Conditions
- SARS-CoV2 infection
- Registration Number
- NL-OMON26590
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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).
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method