ImmuneSense COVID-19 Variant Study

Sponsor

Adaptive Biotechnologies (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05054088

Collaborator

(none)

250

Enrollment

Locations

11.5

Anticipated Duration (Months)

16.7

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Device: T-Detect COVID test

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

ImmuneSense™ COVID-19 Variant Study

Actual Study Start Date :

Oct 11, 2021

Anticipated Primary Completion Date :

Jun 25, 2022

Anticipated Study Completion Date :

Sep 25, 2022

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

Primary Objective: Positive Percent Agreement [Baseline]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

General Inclusion Criteria

Inclusion Criteria:

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Decentralized Trial Model- Phoenix	Phoenix	Arizona	United States	85001
2	Decentralized Trial Model- Fullerton	Fullerton	California	United States	90621
3	Decentralized Trial Model- California	Los Angeles	California	United States	90034
4	Decentralized Trial Model- Modesto	Modesto	California	United States	95313
5	Decentralized Trial Model- Sacramento	Sacramento	California	United States	94203
6	Decentralized Trial Model- California	San Diego	California	United States	22400
7	Decentralized Trial Model- San Francisco	San Francisco	California	United States	94016
8	Decentralized Trial Model- Denver	Denver	Colorado	United States	80014
9	Decentralized Trial Model - Washington D.C.	Washington	District of Columbia	United States	20001
10	Decentralized Trial Model- Florida	Miami	Florida	United States	33101
11	Decentralized Clinical Trial Model- New York City	New York	New York	United States	10001
12	Decentralized Trial Model- Portland	Portland	Oregon	United States	97035
13	Decentralized Trial Model- Utah	Salt Lake City	Utah	United States	84044
14	Decentralized Trial Model- Seattle	Seattle	Washington	United States	98109
15	Decentralized Trial Model- Vancouver, WA	Vancouver	Washington	United States	98607

Sponsors and Collaborators

Adaptive Biotechnologies

Investigators

Principal Investigator: Darcy Gill, PhD, Adaptive Biotechnologies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adaptive Biotechnologies

ClinicalTrials.gov Identifier:

NCT05054088

Other Study ID Numbers:

PRO-00974

First Posted:

Sep 23, 2021

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Adaptive Biotechnologies

Variant

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 2, 2022