ImmuneSense™ COVID-19 Cross-Reactivity Study

Withdrawn before enrolling

Conditions studied: Coronavirus Disease, SARS-CoV-2 Infection

In brief

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.

Key facts

Study ID

NCT05112874

Run by

Adaptive Biotechnologies

People needed

0

Starts

2021-12-15

Expected to finish

2023-05-17

Last updated by the study team

2023-07-27

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Adaptive Biotechnologies — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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