Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
203 participants
OBSERVATIONAL
2021-10-12
2022-07-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
ImmuneSense™ COVID-19 Cross-Reactivity Study
NCT05112874
ImmuneSense Lyme Study
NCT04422314
Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests
NCT02252198
Evaluation of the QuantiFERON-TB Test.
NCT02256839
Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection
NCT04765449
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Subjects who have tested positive for SARS-CoV-2 by EUA RT-PCR testing with symptoms compatible with SARS-CoV-2 infection.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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.
18 Years
89 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Adaptive Biotechnologies
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Darcy Gill, PhD
Role: PRINCIPAL_INVESTIGATOR
Adaptive Biotechnologies
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Decentralized Trial Model- Phoenix
Phoenix, Arizona, United States
Decentralized Trial Model- Fullerton
Fullerton, California, United States
Decentralized Trial Model- California
Los Angeles, California, United States
Decentralized Trial Model- Modesto
Modesto, California, United States
Decentralized Trial Model- Sacramento
Sacramento, California, United States
Decentralized Trial Model- California
San Diego, California, United States
Decentralized Trial Model- San Francisco
San Francisco, California, United States
Decentralized Trial Model- Denver
Denver, Colorado, United States
Decentralized Trial Model - Washington D.C.
Washington D.C., District of Columbia, United States
Decentralized Trial Model- Florida
Miami, Florida, United States
Decentralized Clinical Trial Model- New York City
New York, New York, 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
Decentralized Trial Model- Vancouver, WA
Vancouver, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO-00974
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.