Covid19
Conditions
Keywords
Variant
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.
Interventions
DEVICET-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.
Sponsors
Adaptive Biotechnologies
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed