Cellular & Serological Immune Response Monitoring in SARS-CoV2-infected individuals, without need of hospitalizatio
- Conditions
- Corona virusCOVID-191004743810024970
- Registration Number
- NL-OMON50071
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
• 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).
• 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 invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Absolute counts (relative counts) with comparison to well-defined age-matched<br /><br>reference values. Based on the first results of the BEAT-COVID-1 *sister<br /><br>study*, and the ongoing clinical trials of the Innovative Medicines Initiative<br /><br>(IMI) PERISCOPE program, we expect clear kinetic differences as compared to<br /><br>age-matched reference values. Comparison between the BEAT-COVID-1 results and<br /><br>the newly obtained results from this study will potentially explain the reason<br /><br>of the delays in the antigen-specific immune response in the COVID patients.</p><br>
- Secondary Outcome Measures
Name Time Method