Study to evaluate the analytical performance of the Virax immune COVID-19 flow cytometry kit

Completed

Conditions: COVID-19 testkit
COVID-19 coronavirus

Registration Number: NL-OMON51279

Lead Sponsor: Virax Biolabs Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 96

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety assessments during the study will consist of AEs and SAEs. Clinical<br /><br>laboratory and vital signs measurements will be used to determine eligibility<br /><br>of the subjects. Assessments will be performed in accordance with the schedule<br /><br>of assessments.<br /><br>Subject safety will be monitored from the time each subject signs the ICF until<br /><br>discharge</p><br>

Secondary Outcome Measures