Clinical trial NCT05054088: ImmuneSense COVID-19 Variant Study
Official title: ImmuneSense™ COVID-19 Variant Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Variant
Lead sponsor: Adaptive Biotechnologies
Sponsor class: INDUSTRY
First posted: 2021-09-23
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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.

Primary outcomes:
measure: Primary Objective: Positive Percent Agreement
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Decentralized Trial Model- Phoenix
state: Arizona
city: Fullerton
country: United States
facility: Decentralized Trial Model- Fullerton
state: California
city: Los Angeles
country: United States
facility: Decentralized Trial Model- California
state: California
city: Modesto
country: United States
facility: Decentralized Trial Model- Modesto
state: California
city: Sacramento
country: United States
facility: Decentralized Trial Model- Sacramento
state: California
city: San Diego
country: United States
facility: Decentralized Trial Model- California
state: California
city: San Francisco
country: United States
facility: Decentralized Trial Model- San Francisco
state: California
city: Denver
country: United States
facility: Decentralized Trial Model- Denver
state: Colorado
city: Washington
country: United States
facility: Decentralized Trial Model - Washington D.C.
state: District of Columbia
city: Miami
country: United States
facility: Decentralized Trial Model- Florida
state: Florida
city: New York
country: United States
facility: Decentralized Clinical Trial Model- New York City
state: New York
city: Portland
country: United States
facility: Decentralized Trial Model- Portland
state: Oregon
city: Salt Lake City
country: United States
facility: Decentralized Trial Model- Utah
state: Utah
city: Seattle
country: United States
facility: Decentralized Trial Model- Seattle
state: Washington
city: Vancouver
country: United States
facility: Decentralized Trial Model- Vancouver, WA
state: Washington
Study officials:
affiliation: Adaptive Biotechnologies
name: Darcy Gill, PhD
role: PRINCIPAL_INVESTIGATOR
References: