COVID-19 testkit COVID-19 coronavirus
Conditions
Interventions
None listed
Sponsors
Virax Biolabs Limited
Eligibility
Age
18 Years to 64 Years
Inclusion 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). 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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed