ImmuneSense COVID-19 Variant Study

Study Overview
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Brief Summary
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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.

Official Title
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ImmuneSense™ COVID-19 Variant Study

Conditions
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Covid19

Intervention / Treatment
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* Device: T-Detect COVID test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>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<br>* • 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.<br>|
| Cohort 2<br>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<br>* • 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Variant