Coronavirus DiseaseNCT05112874
ImmuneSense™ COVID-19 Cross-Reactivity Study
An observational study of Coronavirus Disease and SARS-CoV-2 Infection, run by Adaptive Biotechnologies at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Coronavirus Disease, SARS-CoV-2 Infection
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 17 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Coronavirus Disease, SARS-CoV-2 Infection
- Keywords
- COVID-19, SARS-CoV-2, Seasonal Coronavirus, Upper Respiratory Tract Infection
- Medical subject headings
- COVID-19, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15-100 days from symptoms onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start15 Dec 2021
- Primary completion17 May 2023
- Study completion17 May 2023
Why it stopped: Flu season over.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darcy Gill, Principal investigator, Adaptive Biotechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112874
- Sponsor's protocol ID
- PRO-00822
- Status last verified
- Jul 2023
- First submitted
- 27 Oct 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmuneSense™ COVID-19 Cross-Reactivity Study
- ClinicalTrials.gov ID
- NCT05112874
- Acronym / sponsor ID
- PRO-00822
- Conditions
- Coronavirus Disease, SARS-CoV-2 Infection
- Keywords
- COVID-19, SARS-CoV-2, Seasonal Coronavirus, Upper Respiratory Tract Infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Flu season over.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Adaptive BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cross-Reactivity of T-Detect COVID
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darcy Gill principal investigator
Adaptive Biotechnologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease and SARS-CoV-2 Infection, run by Adaptive Biotechnologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-Reactivity of T-Detect COVID (time frame: 15-100 days from symptoms onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.