ImmuneSense COVID-19 Variant Study

ImmuneSense™ COVID-19 Variant Study

This study will assess the clinical performance of the T-Detect™ COVID test to identify an immune response to SARS-CoV-2 infection in the setting of multiple circulating variants of the SARS-CoV-2 virus. Performance may vary depending on the variants circulating at the time of testing, including newly emerging strains of SARS-CoV-2 and their prevalence, which changes over time.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Device: T-Detect COVID test

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85001
      • Decentralized Trial Model- Phoenix
  • California
    • Fullerton, California, United States, 90621
      • Decentralized Trial Model- Fullerton
    • Los Angeles, California, United States, 90034
      • Decentralized Trial Model- California
    • Modesto, California, United States, 95313
      • Decentralized Trial Model- Modesto
    • Sacramento, California, United States, 94203
      • Decentralized Trial Model- Sacramento
    • San Diego, California, United States, 22400
      • Decentralized Trial Model- California
    • San Francisco, California, United States, 94016
      • Decentralized Trial Model- San Francisco
  • Colorado
    • Denver, Colorado, United States, 80014
      • Decentralized Trial Model- Denver
  • District of Columbia
    • Washington, District of Columbia, United States, 20001
      • Decentralized Trial Model - Washington D.C.
  • Florida
    • Miami, Florida, United States, 33101
      • Decentralized Trial Model- Florida
  • New York
    • New York, New York, United States, 10001
      • Decentralized Clinical Trial Model- New York City
  • Oregon
    • Portland, Oregon, United States, 97035
      • Decentralized Trial Model- Portland
  • Utah
    • Salt Lake City, Utah, United States, 84044
      • Decentralized Trial Model- Utah
  • Washington
    • Seattle, Washington, United States, 98109
      • Decentralized Trial Model- Seattle
    • Vancouver, Washington, United States, 98607
      • Decentralized Trial Model- Vancouver, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Prospective ascertainment of a target of 50 whole blood samples (1 sample per individual), and a maximum number of 250 whole blood samples, from individuals between the ages of 18-89 who reside within the United States who have tested positive for SARS-CoV-2 infection via RT-PCR test.

Pregnant women, prisoners, mentally disabled persons, and wards-of-the-state will be excluded to prevent any risk to these vulnerable populations.

Description

General Inclusion Criteria

Inclusion Criteria:

Participants must satisfy the following criteria to be enrolled in the study:

i. Individuals who have tested positive for SARS-CoV-2 via EUA RT-PCR testing. ii. 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. iii. Must be able to communicate with the investigator, understand, and comply with the requirements of the study. iv. Must be able to provide estimated date of symptom onset. v. Must be available for specimen collection greater than 14 days (i.e., 15 days inclusive onward) and less than 107 days (i.e., 106 days inclusive or less) after first exhibiting symptoms of confirmed SARS-CoV-2 infection.

Exclusion Criteria:

The presence of any of the following will exclude a participant from enrollment:

• Individuals who did not test positive for SARS-CoV-2 on EUA RT-PCR.
• 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.
• Exposure to a SARS-CoV-2 investigational drug (new chemical entity) within 60 days prior to enrollment at the discretion of the Sponsor.
• Receipt of immunosuppressive medications, such as, but not limited to, recent moderate- or high-dose systemic steroids or immunomodulators within 1 month prior to enrollment at the discretion of the Sponsor.
• Treatment with immunosuppressants/ immunomodulators that do not impact T cells or B cells may be allowed at the discretion of the Sponsor.
• Steroid formulations including low-dose oral steroids (≤ 10 mg prednisone equivalents per day), inhaled steroids, or topical steroids are not considered exclusionary. Doses >10 and <20 mg prednisone equivalents per day, must receive Sponsor approval.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Subjects who have tested positive for SARS-CoV-2 by EUA RT-PCR testing with symptoms compatible with SARS-CoV-2 infection.	Device: T-Detect COVID test; • The T-DetectTM COVID test is an EUA granted investigational device that is indicated to assess a T-cell immune response to SARS-CoV-2 via the testing of blood samples from patients with signs and symptoms of suspected COVID-19.
Cohort 2; Subjects who have tested positive for SARS-CoV-2 by EUA RT-PCR testing with symptoms compatible with SARS-CoV-2 infection.	Device: T-Detect COVID test; • The T-DetectTM COVID test is an EUA granted investigational device that is indicated to assess a T-cell immune response to SARS-CoV-2 via the testing of blood samples from patients with signs and symptoms of suspected COVID-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective: Positive Percent Agreement	To determine the positive percent agreement (PPA) of the T-Detect™ COVID test with SARS-CoV-2 RT-PCR testing in populations having multiple circulating SARS-CoV-2 variant strains. The primary endpoint is the positive percent agreement (PPA) of the T-Detect™ COVID test with SARS-CoV-2 RT-PCR testing.	Baseline

Collaborators and Investigators

• Sponsor: Adaptive Biotechnologies
• Investigators: Principal Investigator: Darcy Gill, PhD, Adaptive Biotechnologies

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Variant
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PRO-00974

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No