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This study will assess the clinical performance of the T-Detectâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Subjects who have tested positive for SARS-CoV-2 by EUA RT-PCR testing with symptoms compatible with SARS-CoV-2 infection. |
| |
| Cohort 2 | Subjects who have tested positive for SARS-CoV-2 by EUA RT-PCR testing with symptoms compatible with SARS-CoV-2 infection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective: Positive Percent Agreement | To determine the positive percent agreement (PPA) of the T-Detectâ„¢ 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-Detectâ„¢ COVID test with SARS-CoV-2 RT-PCR testing. | Baseline |
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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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Darcy Gill, PhD | Adaptive Biotechnologies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Decentralized Trial Model- Phoenix | Phoenix | Arizona | 85001 | United States | ||
| Decentralized Trial Model- Fullerton |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
| Fullerton |
| California |
| 90621 |
| United States |
| Decentralized Trial Model- California | Los Angeles | California | 90034 | United States |
| Decentralized Trial Model- Modesto | Modesto | California | 95313 | United States |
| Decentralized Trial Model- Sacramento | Sacramento | California | 94203 | United States |
| Decentralized Trial Model- California | San Diego | California | 22400 | United States |
| Decentralized Trial Model- San Francisco | San Francisco | California | 94016 | United States |
| Decentralized Trial Model- Denver | Denver | Colorado | 80014 | United States |
| Decentralized Trial Model - Washington D.C. | Washington D.C. | District of Columbia | 20001 | United States |
| Decentralized Trial Model- Florida | Miami | Florida | 33101 | United States |
| Decentralized Clinical Trial Model- New York City | New York | New York | 10001 | United States |
| Decentralized Trial Model- Portland | Portland | Oregon | 97035 | United States |
| Decentralized Trial Model- Utah | Salt Lake City | Utah | 84044 | United States |
| Decentralized Trial Model- Seattle | Seattle | Washington | 98109 | United States |
| Decentralized Trial Model- Vancouver, WA | Vancouver | Washington | 98607 | United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |