Healthy volunteers blood sampling
- Conditions
- SARS-CoV-2, COVID-19, Corona
- Registration Number
- NL-OMON25763
- Lead Sponsor
- eyden Laboratories B.V.
- Brief Summary
.A.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
1. Participant must sign the study informed consent form prior to any study-mandated procedure indicating that he or she understands the purpose, procedures and potential risks, and is willing to participate in the study;
2. Participant is male or female and between 40 and 65 years of age, inclusive, at the time of enrollment;
3. Participant is willing and able to complete the study procedures;
4. Participant has a primary care physician at the time of enrollment;
5. Participant is generally healthy in the investigator’s clinical judgment, as determined by medical history evaluation, including no clinically significant disorder, condition, infection or disease that would interfere with the study evaluation, procedures or completion.
1. Participant has current clinical symptoms of COVID-19 (including, but not limited to: cough, fever, shortness of breath, sudden onset of anosmia, ageusia or dysgeusia). Note that a participant who reports a previous positive diagnostic test result for SARS-CoV-2 infection (serological testing or viral RNA detection by PCR testing) and who is recovered from COVID-19 for at least three weeks prior to blood sampling is allowed to participate in the study as deemed by the investigator;
2. Participant had recent close contact with a SARS-CoV-2 infected person or someone in their household tested positive for SARS-CoV-2, has travelled to a country/area that has been designated as a COVID-19 risk area according to the effective policies/guidelines of the National Institute for Public Health and the Environment (Dutch: RIVM) or otherwise meet criteria for home isolation;
3. Participant received immunosuppressive medication or other immunomodulating agents (including investigational drugs) in the 3 weeks prior to study blood sampling or received immunoglobulins or blood products in the 3 months prior to study blood sampling;
4. Participant with a whole blood donation or loss of >500 ml within 21 days before study blood sampling;
5. Any known factor, condition, or disease that might interfere with compliance, study conduct or interpretation of the results, as deemed by the investigator.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • B-cell response as assessed by enzyme-linked immunosorbent assay (ELISA) and/or enzyme-linked immunosorbent spot assay (ELISpot) and/or flow cytometry methods<br>• Serology: peptide library scanning<br>
- Secondary Outcome Measures
Name Time Method • Prevalence of common cold as assessed by PCR-based assay for respiratory pathogens panel