NCT04583982

ImmuneSense™ COVID-19 Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: Adaptive Biotechnologies · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Coronavirus disease is of an urgent global priority. The purpose of ImmuneSense™ COVID-19 study is to evaluate the clinical performance and to provide data for clinical validation for the T-Detect™ SARS-CoV-2 (previously referred to as immunoSEQ Dx SARS-CoV-2) Assay in support of Adaptive's Emergency Use Authorization (EUA) request for T-Detect™ SARS-CoV-2 and secondary aims. This assay is intended to detect immune response to the virus that causes coronavirus disease (COVID-19), SARS-CoV-2. This is critically important because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease that current tests cannot.

Detailed description

Comprehensive diagnostic testing has an important role to play in the control and containment of the current pandemic. Adaptive Biotechnologies Corporation (Adaptive) has developed an immunosequencing technology, called immunoSEQ®, which utilizes polymerase chain reaction (PCR) and next-generation sequencing (NGS) to identify and quantify rearranged T-cell receptor (TCR) gene sequences from peripheral blood, collectively referred to as the T-cell repertoire. The T-cell repertoire can be further analyzed using indication-specific algorithms that are based on disease-associated TCR sequences. Adaptive has developed a clinical test called T-Detect™ SARS-CoV-2, which is intended to identify a T-cell response to the SARS-CoV-2 virus, indicating recent or prior infection. In this investigational study, Adaptive plans to clinically validate samples acquired from patients with COVID-19 and present results for an eventual EUA-submission for the T-Detect™ SARS-CoV-2 Assay. T-Detect™ SARS-CoV-2 is a single-site assay performed at Adaptive Biotechnologies Corporation.

Conditions

• Coronavirus Disease (COVID-19)
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
OTHER	T-Detect™ SARS-CoV-2 Assay	T-Detect™ SARS-CoV-2 Assay is an investigational device that is indicated to assess T-cell immune response to SARS-CoV-2 via the testing of blood samples from patients with signs and symptoms of suspected COVID-19. These results will not be shared with the participant.

Timeline

• Start date: 2020-10-09
• Primary completion: 2020-12-04
• Completion: 2020-12-04
• First posted: 2020-10-12
• Last updated: 2022-04-15

Locations

1 site across 1 country: United States