ImmuneSense™ COVID-19 Cross-Reactivity Study

Sponsor

Adaptive Biotechnologies (Industry)

Overall Status

Suspended

CT.gov ID

NCT05112874

Collaborator

(none)

Enrollment

Location

16.5

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adaptive Biotechnologies has developed a clinical test called T-Detect COVID Test that can identify a T-cell response to the SARS-CoV-2 virus, indicating recent or prior infection This study aims to evaluate the potential cross-reactivity of the T-Detect COVID test in participants presenting with viral upper respiratory tract infections within the assay's intended use population and testing positive for seasonal coronavirus.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Disease SARS-CoV-2 Infection

Detailed Description

Prospective ascertainment of a minimum of 10 individuals exhibiting symptoms of viral upper respiratory tract infections, between the ages of 18-89 residing within the United States and being tested for SARS-CoV-2 infection during the 2021-2022 cold and flu season (~Nov. 2021 - May 2022).

Participants will complete an electronic screening questionnaire to determine eligibility, be consented, and scheduled for a study visit that will be conducted by study staff or mobile phlebotomist. The identification and recruitment of participants will protect privacy and be free of undue influence. Biological samples, including blood samples and nasopharyngeal swabs, will be collected via mobile phlebotomy in participant's homes with proper safety precautions in place. Study metadata and questionnaire information will be self-reported and/or recorded by study staff as applicable.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

ImmuneSense™ COVID-19 Cross-Reactivity Study

Actual Study Start Date :

Dec 15, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Prospective Cross-Reactive Cohort Ages 18-89, Exhibiting symptoms compatible with a viral upper respiratory tract infection at the time of screening. Lab test confirming Negative for SARS-CoV-2 (by Polymerase Chain Reaction (PCR) or Antibody detection test) Respiratory Panel positive for the common seasonal coronaviruses: NL63, 229E, OC43, and HKU1

Outcome Measures

Primary Outcome Measures

Cross-Reactivity of T-Detect COVID [15-100 days from symptoms onset]
Adaptive Biotechnologies Corporation has developed a clinical test called T-Detect COVID, which is intended to identify a T-cell response to the SARS-CoV-2 virus, indicating recent or prior infection. This study will assess the clinical performance of the T-Detect COVID test in participants presenting with symptoms of a viral upper respiratory tract infections. Eligible participants must have proof of negative result from an Emergency Use Authorization approved Reverse transcription-polymerase chain reaction (RT-PCR) assay and positive result with Clinical Laboratory Improvement Amendment (CLIA) validated assay for other seasonal coronaviruses.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Exhibiting viral upper respiratory infection symptoms during the symptomatic phase of infection and tested positive for a common seasonal coronavirus (NL63, 229E, OC43, and HKU1) at time of diagnosis for initial symptoms
Available for specimen collection greater than 14 days and less than 100 days after first exhibiting symptoms of confirmed seasonal coronavirus infection.
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
Able to communicate with the investigator, understand, and comply with the requirements of the study

Exclusion criteria:

Did not develop symptoms related to their diagnosed seasonal coronavirus infection
Prior diagnosis of COVID-19 or any positive test result for SARS-CoV-2 infection or antibodies test
Cohabitated with or has had significant exposure (per the Center for Disease Control guidelines) to another individual with known COVID-19
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
Donated more than 500cc or 1 pint of blood in the past 60 days prior to the study blood draw
Received a COVID-19 vaccine, including a single dose of a multiple dose vaccine regimen
Participated in a COVID-19/SARS-CoV-2 study or received a SARS-CoV-2 antibody, or other SARS-CoV-2 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 SARS-CoV-2 antibody, therapeutic, or other medication that may impact the person's immune response