ImmuneSense™ COVID-19 Study

NCT04583982 | Completed DMC

• 1 other identifier: PRO-00781
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

COVID-19; SARS-CoV-2; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Demonstrate clinical agreement of T-Detect™ SARS-CoV-2 Assay

  To demonstrate the clinical agreement of the T-Detect™ SARS-CoV-2 Assay in participants with a positive and negative result from an EUA approved RT-PCR assay.

  Initial Visit

Study Arms (1)

Prospective Study Arm SARS-CoV-2 negative and positive samples

Other: T-Detect™ SARS-CoV-2 Assay

Interventions

T-Detect™ SARS-CoV-2 Assay OTHER

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.

Prospective Study Arm SARS-CoV-2 negative and positive samples

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants include male and female participants, of any race and ethnicity, ages 18-89.

You may qualify if:

• Participants must satisfy the following criteria to be enrolled in the study:
• Currently symptomatic individuals who are being tested for SARS-CoV-2 infection by nasopharyngeal swab
• Male and female participants of any race and ethnicity between 18 to 89 years of age (inclusive) at the time of enrolling in the study
• Must be able to communicate with the investigator, understand, and comply with the requirements of the study

You may not qualify if:

• The presence of any of the following will exclude a participant from enrollment:
• Asymptomatic individuals who are being tested for SARS-CoV-2 infection
• Prior confirmed diagnosis of COVID-19
• Any person who cohabitated with another individual with known COVID-19
• Protected populations including minors, 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 blood draw
• Participation in a COVID-19/SARS-CoV-2 study or received a COVID-19 vaccine, antibody, or other COVID-19 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 COVID-19 antibody, therapeutic, or other medication that will impact the person's immune system

Sponsors & Collaborators

• Adaptive Biotechnologies: lead
• Covance: collaborator

Study Sites (1)

Adaptive Biotechnologies Clinical Investigational Site

Secaucus, New Jersey, 07094, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Namita Singh, MD

  Medical Director, Clinical Development

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 12, 2020
• Study Start: October 9, 2020
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)