ImmuneSense™ COVID-19 Cross-Reactivity Study

NCT05112874 | Withdrawn

• 1 other identifier: PRO-00822
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease; SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2; Seasonal Coronavirus; Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• Cross-Reactivity of T-Detect COVID

  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.

  15-100 days from symptoms onset

Study Arms (1)

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 1. Negative for SARS-CoV-2 (by Polymerase Chain Reaction (PCR) or Antibody detection test) 2. Respiratory Panel positive for the common seasonal coronaviruses: NL63, 229E, OC43, and HKU1

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruiting individuals ages 18-89 at the time of screening are exhibiting symptoms compatible with a viral upper respiratory tract infection and obtain negative test result for SARS-CoV-2. Eligible participants must also test positive for one of the following common seasonal coronaviruses: NL63, 229E, OC43, and HKU1 via Respiratory Panel test.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adaptive Biotechnologies: lead

Study Sites (1)

Adaptive Biotechnologies

Seattle, Washington, 98102, United States

Location

MeSH Terms

Conditions

COVID-19; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Darcy Gill

  Adaptive Biotechnologies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 9, 2021
• Study Start: December 15, 2021
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)