ImmuneSense COVID-19 Variant Study

NCT05054088 | Completed

• 1 other identifier: PRO-00974
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Covid19

Keywords

Variant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

T-Detect COVID test DEVICE

• 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 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adaptive Biotechnologies: lead

Study Sites (15)

Decentralized Trial Model- Phoenix

Phoenix, Arizona, 85001, United States

Location

Decentralized Trial Model- Fullerton

Fullerton, California, 90621, United States

Location

Decentralized Trial Model- California

Los Angeles, California, 90034, United States

Location

Decentralized Trial Model- Modesto

Modesto, California, 95313, United States

Location

Decentralized Trial Model- Sacramento

Sacramento, California, 94203, United States

Location

Decentralized Trial Model- California

San Diego, California, 22400, United States

Location

Decentralized Trial Model- San Francisco

San Francisco, California, 94016, United States

Location

Decentralized Trial Model- Denver

Denver, Colorado, 80014, United States

Location

Decentralized Trial Model - Washington D.C.

Washington D.C., District of Columbia, 20001, United States

Location

Decentralized Trial Model- Florida

Miami, Florida, 33101, United States

Location

Decentralized Clinical Trial Model- New York City

New York, New York, 10001, United States

Location

Decentralized Trial Model- Portland

Portland, Oregon, 97035, United States

Location

Decentralized Trial Model- Utah

Salt Lake City, Utah, 84044, United States

Location

Decentralized Trial Model- Seattle

Seattle, Washington, 98109, United States

Location

Decentralized Trial Model- Vancouver, WA

Vancouver, Washington, 98607, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be collected in volumes of 5 mL (1 x 10 mL K2 EDTA tube) for each participant. It will be considered a protocol deviation if less than 2mL of whole blood is collected per tube All whole blood samples collected during the study visit will be shipped ambiently to Adaptive. Upon arrival at Adaptive, blood will undergo DNA extraction, and the T-Detect TM COVID test will be performed as applicable and per laboratory protocols. Additional assays may be applied.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Darcy Gill, PhD

  Adaptive Biotechnologies

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 23, 2021
• Study Start: October 12, 2021
• Primary Completion: July 20, 2022
• Study Completion: July 28, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)