ImmuneSenseâ„¢ COVID-19 Cross-Reactivity Study (NCT05112874) | Clinical Trial Compass
WithdrawnNot Applicable
ImmuneSenseâ„¢ COVID-19 Cross-Reactivity Study
Stopped: Flu season over.
United States0Started 2021-12-15
Plain-language summary
Adaptive Biotechnologies has developed a clinical test called T-Detect COVID Test that can identify a T-cell response to the SARS-CoV-2 virus, indicating recent or prior infection This study aims to evaluate the potential cross-reactivity of the T-Detect COVID test in participants presenting with viral upper respiratory tract infections within the assay's intended use population and testing positive for seasonal coronavirus.
Who can participate
Age range18 Years – 89 Years
SexALL
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Inclusion criteria
✓. Exhibiting viral upper respiratory infection symptoms during the symptomatic phase of infection and tested positive for a common seasonal coronavirus (NL63, 229E, OC43, and HKU1) at time of diagnosis for initial symptoms
✓. Available for specimen collection greater than 14 days and less than 100 days after first exhibiting symptoms of confirmed seasonal coronavirus infection.
✓. Male and female participants of any race and ethnicity between 18 to 89 years of age (inclusive) at the time of enrollment in the study
✓. Able to communicate with the investigator, understand, and comply with the requirements of the study
Exclusion criteria
✕. Did not develop symptoms related to their diagnosed seasonal coronavirus infection
✕. Prior diagnosis of COVID-19 or any positive test result for SARS-CoV-2 infection or antibodies test
✕. Cohabitated with or has had significant exposure (per the Center for Disease Control guidelines) to another individual with known COVID-19
✕. Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state.
✕. Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
✕. Donated more than 500cc or 1 pint of blood in the past 60 days prior to the study blood draw
. Received a COVID-19 vaccine, including a single dose of a multiple dose vaccine regimen
✕. Participated in a COVID-19/SARS-CoV-2 study or received a SARS-CoV-2 antibody, or other SARS-CoV-2 therapeutic investigational drug or compound that will impact results of the study at the discretion of the investigator, such as but not limited to a SARS-CoV-2 antibody, therapeutic, or other medication that may impact the person's immune response