NCT05112874

ImmuneSense™ COVID-19 Cross-Reactivity Study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Adaptive Biotechnologies · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: —

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.

Detailed description

Prospective ascertainment of a minimum of 10 individuals exhibiting symptoms of viral upper respiratory tract infections, between the ages of 18-89 residing within the United States and being tested for SARS-CoV-2 infection during the 2021-2022 cold and flu season (\~Nov. 2021 - May 2022). Participants will complete an electronic screening questionnaire to determine eligibility, be consented, and scheduled for a study visit that will be conducted by study staff or mobile phlebotomist. The identification and recruitment of participants will protect privacy and be free of undue influence. Biological samples, including blood samples and nasopharyngeal swabs, will be collected via mobile phlebotomy in participant's homes with proper safety precautions in place. Study metadata and questionnaire information will be self-reported and/or recorded by study staff as applicable.

Conditions

• Coronavirus Disease
• SARS-CoV-2 Infection

Timeline

• Start date: 2021-12-15
• Primary completion: 2023-05-17
• Completion: 2023-05-17
• First posted: 2021-11-09
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States