SARS-Cov-2, Covid19NCT04699903
Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood
An observational study of SARS-Cov-2, Covid19, run by Lumos Diagnostics at 3 sites in United States.
Trial summary
Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- SARS-Cov-2, Covid19
- What is being tested?
- POC SARS-Cov-2 IgG Antibody test
- How many people
- 201 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Jan 2021to 9 Apr 2021
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in the outpatient setting with EUA PCR test results who meet inclusion and exclusion criteria are eligible for the study.
Who may be able to join
- Patients with high-sensitive EUA PCR results (positive result)
- Previous diagnostic of SARS-Cov-2
- Signed informed consent
- Patients with high-sensitive EUA PCR results (negative result)
- Signed informed consent
Who cannot join
- Missing PCR results
- Results from a non-high-sensitive PCR test
- Negative Cohort
- Missing PCR results
- Results from a non-high-sensitive PCR test
- Previous diagnostic of SARS-Cov-2
- History of a positive SARS-CoV-2 antibody test (IgG, IgM or Total Antibody)
- Negative SARS-Cov-2 PCR result that occurred > 7 days from study visit
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Great Lakes Clinical Trials (GLCT)
Chicago, Illinois, 60640
Benchmark - SoCal
Colton, California, 92324
Comprehensive Clinical Research
West Palm Beach, Florida, 33409
About this study
Official title: Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 IgG Antibody Test in Fingerstick Whole Blood
Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood.
Read the detailed description
Patients with PCR testing in outpatient setting will be screened and asked to participate in the study.
Subjects with a positive diagnosis of COVID-19 confirmed by a positive, EUA SARS-CoV-2 PCR test will be stratified by the number of days since first symptom onset (i.e. 0-7, 8-14, or >15 days) in the positive cohort Subjects with a negative diagnosis of COVID-19 confirmed by a negative, EUA SARS-CoV-2 PCR test within 0-7 days of PCR sample collection will be included in the negative cohort.
Treating clinicians, clinical research coordinators and study subjects will be blinded to the POC test results.
Quality assurance will be assured with site monitoring to check accuracy and completeness of data entered.
- Conditions
- SARS-Cov-2, Covid19
- Being tested
- POC SARS-Cov-2 IgG Antibody test
- Keywords
- IgG, Point of care testing, EUA
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC SARS-Cov-2 IgG Antibody testDiagnostic test
All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood
| Study group | Role | What they receive |
|---|---|---|
| Positive SARS-Cov-2 cohort | Positive diagnosis of COVID-19 confirmed by a positive EUA SARS-CoV-2 PCR will be stratified in three subgroups 0 - 7 days since onset of symptoms 8 - 14 days since onset of symptoms 15 -90 days since onset of symptoms Receives: Diagnostic Test: POC SARS-Cov-2 IgG Antibody test | |
| Negative SARS-Cov-2 cohort | Negative diagnosis of COVID-19 confirmed by a negative, EUA SARS-CoV-2 PCR test within 0-7 days of PCR sample collection will be included in the negative cohort. Receives: Diagnostic Test: POC SARS-Cov-2 IgG Antibody test |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPA (positive percent agreement) and NPA (negative percent agreement) of POC compared to SARS-CoV-2 reference PCR
Determine PPA and NPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
Measured: 0-7 days
PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR
Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
Measured: 8-14 days
PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR
Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
Measured: 15 - 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start5 Jan 2021
- Primary completion29 Jan 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-Cov-2, Covid19Studies 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
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rapid Pathogen Screening
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699903
- Sponsor's protocol ID
- 20-1106
- Status last verified
- Jun 2021
- First submitted
- 29 Dec 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 IgG Antibody Test in Fingerstick Whole Blood
- ClinicalTrials.gov ID
- NCT04699903
- Acronym / sponsor ID
- 20-1106
- Conditions
- SARS-Cov-2, Covid19
- Keywords
- IgG, Point of care testing, EUA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Lumos DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Rapid Pathogen Screening
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 7 Jan 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.
Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood.
Detailed description
Patients with PCR testing in outpatient setting will be screened and asked to participate in the study.
Subjects with a positive diagnosis of COVID-19 confirmed by a positive, EUA SARS-CoV-2 PCR test will be stratified by the number of days since first symptom onset (i.e. 0-7, 8-14, or >15 days) in the positive cohort Subjects with a negative diagnosis of COVID-19 confirmed by a negative, EUA SARS-CoV-2 PCR test within 0-7 days of PCR sample collection will be included in the negative cohort.
Treating clinicians, clinical research coordinators and study subjects will be blinded to the POC test results.
Quality assurance will be assured with site monitoring to check accuracy and completeness of data entered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive SARS-Cov-2 cohort | – | Diagnostic Test: POC SARS-Cov-2 IgG Antibody testPositive diagnosis of COVID-19 confirmed by a positive EUA SARS-CoV-2 PCR will be stratified in three subgroups 0 - 7 days since onset of symptoms 8 - 14 days since onset of symptoms 15 -90 days since onset of symptoms |
| Negative SARS-Cov-2 cohort | – | Diagnostic Test: POC SARS-Cov-2 IgG Antibody testNegative diagnosis of COVID-19 confirmed by a negative, EUA SARS-CoV-2 PCR test within 0-7 days of PCR sample collection will be included in the negative cohort. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in the outpatient setting with EUA PCR test results who meet inclusion and exclusion criteria are eligible for the study.
Key inclusion criteria (5 listed)
- Patients with high-sensitive EUA PCR results (positive result)
- Previous diagnostic of SARS-Cov-2
- Signed informed consent
- Patients with high-sensitive EUA PCR results (negative result)
- Signed informed consent
Key exclusion criteria (8 listed)
- Missing PCR results
- Results from a non-high-sensitive PCR test
- Negative Cohort
- Missing PCR results
- Results from a non-high-sensitive PCR test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POC SARS-Cov-2 IgG Antibody testAll patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood | Diagnostic test | Negative SARS-Cov-2 cohort, Positive SARS-Cov-2 cohort |
Primary outcome
PPA (positive percent agreement) and NPA (negative percent agreement) of POC compared to SARS-CoV-2 reference PCR
Time frame: 0-7 days
Determine PPA and NPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR
Time frame: 8-14 days
Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR
Time frame: 15 - 90 days
Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
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 18 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-Cov-2, Covid19, run by Lumos Diagnostics at 3 sites 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 5 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: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
PPA (positive percent agreement) and NPA (negative percent agreement) of POC compared to SARS-CoV-2 reference PCR (time frame: 0-7 days). The study lists 3 primary outcomes in all. 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 18 Jun 2021.