ImmuneSense COVID-19 Variant Study

Covid19 Clinical Trial

Official title:

ImmuneSense™ COVID-19 Variant Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05054088
• Other study ID #: PRO-00974
• Status: Completed
• Start date: October 12, 2021
• Est. completion date: July 28, 2022

Study information

• Verified date: December 2022
• Source: Adaptive Biotechnologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 28, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Decentralized Trial Model- Denver	Denver	Colorado
United States	Decentralized Trial Model- Fullerton	Fullerton	California
United States	Decentralized Trial Model- California	Los Angeles	California
United States	Decentralized Trial Model- Florida	Miami	Florida
United States	Decentralized Trial Model- Modesto	Modesto	California
United States	Decentralized Clinical Trial Model- New York City	New York	New York
United States	Decentralized Trial Model- Phoenix	Phoenix	Arizona
United States	Decentralized Trial Model- Portland	Portland	Oregon
United States	Decentralized Trial Model- Sacramento	Sacramento	California
United States	Decentralized Trial Model- Utah	Salt Lake City	Utah
United States	Decentralized Trial Model- California	San Diego	California
United States	Decentralized Trial Model- San Francisco	San Francisco	California
United States	Decentralized Trial Model- Seattle	Seattle	Washington
United States	Decentralized Trial Model- Vancouver, WA	Vancouver	Washington
United States	Decentralized Trial Model - Washington D.C.	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Adaptive Biotechnologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective: Positive Percent Agreement	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.	Baseline