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ImmuneSense™ COVID-19 Study

NCT04583982 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2022-04-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Adaptive Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Namita Singh, MD · Medical Director, Clinical Development

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-09
Primary Completion
2020-12-04
Completion
2020-12-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04583982 on ClinicalTrials.gov