COVID-19NCT05080231
COVID-19 Immunity Assessment
An observational study of COVID-19, run by DxTerity Diagnostics at 1 site in United States.
Trial summary
The purpose of this study is to collect blood specimens from individuals post infection or post vaccination over time to assess COVID19 Immunity. Read more about this study
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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Males and females ≥13 years old. Not vaccinated and were previously positive for COVID-19 OR are vaccinated for COVID-19. Provides test report to demonstrate prior COVID-19 positive result (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects). Provides informed consent and completed questionnaire. Able to register the collection kit on the DxTerity portal. Able to collect and ship blood samples back to DxTerity.
Who may be able to join
- Males and females ≥13 years old.
- Not vaccinated and were previously positive for COVID-19 OR are vaccinated for COVID-19.
- Provides test report to demonstrate prior COVID-19 positive result (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
- Provides informed consent and completed questionnaire.
- Able to register the collection kit on the DxTerity portal.
- Able to collect and ship blood samples back to DxTerity.
Who cannot join
- Unable to provide COVID-19 positive test report (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
- Unable to complete informed consent and/or questionnaire.
- Unable to complete the study activities in a timely manner.
Trial locations and contacts
1 site in 1 country.
United States1 site
DxTerity Diagnostics Inc.
Compton, California, 90220
About this study
Official title: Blood Specimen Collection for COVID-19 Immunity Assessment Mailer Kit Clinical Study
The purpose of this study is to collect blood specimens from individuals post infection or post vaccination over time to assess COVID19 Immunity.
Read the detailed description
The DxTerity COVID-19 Immunity Assessment Collection Mailer Kit contains the DxCollect MicroCollection Device (MCD) Serology fingerstick blood collection device packaged as a home collection kit, designed for collection and shipment of fingerstick blood back to DxTerity CLIA (Clinical Laboratory Improvements Amendment) certified laboratory for testing.
The clinical performance of the collection device for use with anti-SARS-CoV-2 antibody tests will be evaluated for use with cPASS™ anti-SARS-CoV-2 neutralizing antibody detection kit (EUA 201427).
The samples may also be used for assessing immunity or protection post COVID-19 vaccination.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
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 |
|---|---|---|
| COVID-19 Vaccinated Individuals | Males and females, 13years old and above, vaccinated for COVID-19 | |
| Previously positive for COVID-19 and unvaccinated individuals | Males and females, 13years old and above, unvaccinated for COVID-19 and previously tested positive for COVID-19. | |
| No previous COVID infection or vaccination | Males and females, 13years old and above, unvaccinated for COVID-19 and previously not tested positive for COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing Antibody Levels
Measuring neutralizing antibody levels with COVID-19 immunity assessment test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start15 Jul 2021
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- DxTerity Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080231
- Sponsor's protocol ID
- PROT-0239
- Status last verified
- Aug 2023
- First submitted
- 13 Oct 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Specimen Collection for COVID-19 Immunity Assessment Mailer Kit Clinical Study
- ClinicalTrials.gov ID
- NCT05080231
- Acronym / sponsor ID
- PROT-0239
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- DxTerity DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 15 Oct 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.
The purpose of this study is to collect blood specimens from individuals post infection or post vaccination over time to assess COVID19 Immunity.
Detailed description
The DxTerity COVID-19 Immunity Assessment Collection Mailer Kit contains the DxCollect MicroCollection Device (MCD) Serology fingerstick blood collection device packaged as a home collection kit, designed for collection and shipment of fingerstick blood back to DxTerity CLIA (Clinical Laboratory Improvements Amendment) certified laboratory for testing.
The clinical performance of the collection device for use with anti-SARS-CoV-2 antibody tests will be evaluated for use with cPASS™ anti-SARS-CoV-2 neutralizing antibody detection kit (EUA 201427).
The samples may also be used for assessing immunity or protection post COVID-19 vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Vaccinated Individuals | – | –Males and females, 13years old and above, vaccinated for COVID-19 |
| Previously positive for COVID-19 and unvaccinated individuals | – | –Males and females, 13years old and above, unvaccinated for COVID-19 and previously tested positive for COVID-19. |
| No previous COVID infection or vaccination | – | –Males and females, 13years old and above, unvaccinated for COVID-19 and previously not tested positive for COVID-19. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males and females ≥13 years old. Not vaccinated and were previously positive for COVID-19 OR are vaccinated for COVID-19. Provides test report to demonstrate prior COVID-19 positive result (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects). Provides informed consent and completed questionnaire. Able to register the collection kit on the DxTerity portal. Able to collect and ship blood samples back to DxTerity.
Key inclusion criteria (6 listed)
- Males and females ≥13 years old.
- Not vaccinated and were previously positive for COVID-19 OR are vaccinated for COVID-19.
- Provides test report to demonstrate prior COVID-19 positive result (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
- Provides informed consent and completed questionnaire.
- Able to register the collection kit on the DxTerity portal.
Key exclusion criteria (3 listed)
- Unable to provide COVID-19 positive test report (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
- Unable to complete informed consent and/or questionnaire.
- Unable to complete the study activities in a timely manner.
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
Neutralizing Antibody Levels
Time frame: 3 months
Measuring neutralizing antibody levels with COVID-19 immunity assessment test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Active, not recruitingObservational study
A Study to Learn About COVID-19 Antivirals in People With SARS-CoV-2 Infection From 2023-2026
COVID-19 SARS-CoV-2 Infection
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19, run by DxTerity Diagnostics 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 14 Aug 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neutralizing Antibody Levels (time frame: 3 months). 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 14 Aug 2023.