ImmuneSense COVID-19 Variant Study

Completed

• Conditions: Covid19
• Interventions: Device: T-Detect COVID test

• Registration Number: NCT05054088
• Lead Sponsor: Adaptive Biotechnologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-09-23
• Study Start: 2021-10-12
• Primary Completion: 2022-07-20
• Study Completion: 2022-07-28
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2	T-Detect COVID test	Subjects who have tested positive for SARS-CoV-2 by EUA RT-PCR testing with symptoms compatible with SARS-CoV-2 infection.
Cohort 1	T-Detect COVID test	Subjects who have tested positive for SARS-CoV-2 by EUA RT-PCR testing with symptoms compatible with SARS-CoV-2 infection.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (14)

Decentralized Trial Model- Modesto; 🇺🇸 Modesto, California, United States

Decentralized Trial Model- Sacramento; 🇺🇸 Sacramento, California, United States

Decentralized Trial Model - Washington D.C.; 🇺🇸 Washington, District of Columbia, United States

Decentralized Clinical Trial Model- New York City; 🇺🇸 New York, New York, United States

Decentralized Trial Model- Vancouver, WA; 🇺🇸 Vancouver, Washington, United States

Decentralized Trial Model- Phoenix; 🇺🇸 Phoenix, Arizona, United States

Decentralized Trial Model- California; 🇺🇸 San Diego, California, United States

Decentralized Trial Model- Fullerton; 🇺🇸 Fullerton, California, United States

Decentralized Trial Model- Denver; 🇺🇸 Denver, Colorado, United States

Decentralized Trial Model- San Francisco; 🇺🇸 San Francisco, California, United States

Decentralized Trial Model- Florida; 🇺🇸 Miami, Florida, United States

Decentralized Trial Model- Portland; 🇺🇸 Portland, Oregon, United States

Decentralized Trial Model- Utah; 🇺🇸 Salt Lake City, Utah, United States

Decentralized Trial Model- Seattle; 🇺🇸 Seattle, Washington, United States