Investigation of the performance of the Virax Immune COVID-19 kit when tested using blood donations from healthy participants.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
COVID-19 testkit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety assessments during the study will consist of AEs and SAEs. Clinical
laboratory and vital signs measurements will be used to determine eligibility
of the subjects. Assessments will be performed in accordance with the schedule
of assessments.
Subject safety will be monitored from the time each subject signs the ICF until
discharge
Secondary outcome
not applicable
Background summary
The Virax Immune COVID-19 kit is a new test that could potentially be used to
measure the immune response to the virus that causes coronavirus disease 2019
(COVID-19). This is measured in blood samples. This immune response involves
immune cells that produce specific proteins in response. For the lab test,
these immune cells are stimulated in the blood with parts of the virus protein
to see if and how much of the specific proteins are produced. The amount of
those specific proteins is a measure of the strength of the immune response and
is a measure of protection against COVID-19. Because immune cells also contain
memory cells, this test can also be used to determine the longer-term
protection against COVID-19, for example after vaccination
Study objective
Investigation of the performance of the Virax Immune COVID-19 kit when tested
using blood donations from healthy participants.
Study design
For the research it is necessary that the volunteer makes 1 visit to the
research center on Day 1.
For the test, 4 tubes of blood of 9 ml are taken. (total 36ml)
During the examination, the following examinations and measurements are made:
• Blood test. Blood is taken for this.
• The volunteer is asked how he/she is feeling and if there are any other
details that have to do with his/her health
Study burden and risks
blood draw and coronavirus test
Bloomsbury Square 4
London WC1A 2RP
GB
Bloomsbury Square 4
London WC1A 2RP
GB
Listed location countries
Age
Inclusion criteria
1. Sex: male or female; females may be of childbearing potential, of
nonchildbearing potential, or postmenopausal.
2. Age: 18 to 65 years, inclusive, on the day of consent.
3. Status: healthy subject. Good physical and mental health on the basis of
medical history and vital signs, as judged by the Investigator.
4. Females must be nonpregnant; nonpregnancy will be confirmed for all females
by a urine pregnancy test.
5. Nonsteroid anti-inflammatory drugs (ie, ibuprofen, diclofenac, etc.) must
have been stopped at least 48 hours prior to admission to the clinical research
center (evaluation through questionnaire).
6. Fluent in the language of the clinical site (Dutch) and able to read in this
language.
7. Willing and able to sign the ICF and comply with study procedures.
8. Positive SARS-CoV-2 test (preferably by nasopharyngeal PCR) within 4 months
prior to, but not on the day of consent.
Exclusion criteria
1. Previous participation in the current study.
2. Employee of ICON or the Sponsor.
3. Having an underlying blood disorder, like leukemia (evaluation through
questionnaire).
4. Known to have human anti mouse antibodies (ie, HAMA response; evaluation
through questionnaire).
5. Taking immune suppressive medication, or receiving chemotherapy, cytokine or
anti-cytokine therapy, or antithrombotic medication (evaluation through
questionnaire).
more conditions apply
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80952.056.22 |