ImmuneSense™ COVID-19 Study

Completed

Conditions studied: Coronavirus Disease (COVID-19), SARS-CoV-2 Infection

In brief

Coronavirus disease is of an urgent global priority. The purpose of ImmuneSense™ COVID-19 study is to evaluate the clinical performance and to provide data for clinical validation for the T-Detect™ SARS-CoV-2 (previously referred to as immunoSEQ Dx SARS-CoV-2) Assay in support of Adaptive's Emergency Use Authorization (EUA) request for T-Detect™ SARS-CoV-2 and secondary aims. This assay is intended to detect immune response to the virus that causes coronavirus disease (COVID-19), SARS-CoV-2. This is critically important because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease that current tests cannot.

Key facts

Study ID

NCT04583982

Run by

Adaptive Biotechnologies

People needed

180

Starts

2020-10-09

Expected to finish

2020-12-04

Last updated by the study team

2022-04-15

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must satisfy the following criteria to be enrolled in the study:
• Currently symptomatic individuals who are being tested for SARS-CoV-2 infection by nasopharyngeal swab
• Male and female participants of any race and ethnicity between 18 to 89 years of age (inclusive) at the time of enrolling in the study
• Must be able to communicate with the investigator, understand, and comply with the requirements of the study

You may not qualify if…

• The presence of any of the following will exclude a participant from enrollment:
• Asymptomatic individuals who are being tested for SARS-CoV-2 infection
• Prior confirmed diagnosis of COVID-19
• Any person who cohabitated with another individual with known COVID-19
• Protected populations including minors, 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
• Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw
• Participation in a COVID-19/SARS-CoV-2 study or received a COVID-19 vaccine, antibody, or other COVID-19 therapeutic Investigational drug or compound that will impact results of the study at the discretion of the investigator, such as but not limited to a COVID-19 antibody, therapeutic, or other medication that will impact the person's immune system

Where it is running

• Adaptive Biotechnologies Clinical Investigational Site — Secaucus, New Jersey, United States

Full record on ClinicalTrials.gov

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