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Clinical Trials/NL-OMON51279
NL-OMON51279
Completed
Not Applicable

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 sites96 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19 testkit
Sponsor
Virax Biolabs Limited
Enrollment
96
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

Investigators

Sponsor
Virax Biolabs Limited

Eligibility Criteria

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).

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

Outcomes

Primary Outcomes

Not specified

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