Study to evaluate the analytical performance of the Virax immune COVID-19 flow cytometry kit - Blood Sampling for Virax Immune COVID*19 Testing

Virax Biolabs Limited0 个研究点目标入组 96 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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
•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.

•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

发起方

Virax Biolabs Limited