Covid19NOVIR POCNCT04902911
Point of Care Evaluation of Novir 2019-nCoV Immunoglobulin G/ Immunoglobulin M (IgG/IgM) Antibody Test (Collodial Gold)
An observational study of Covid19, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This clinical study is designed to test the efficacy of the Novir 2019-nCoV Immunoglobulin M/Immunoglobulin G Antibody Test in a point-of-care setting to support the increasing need for rapid screening in the detection of antibodies. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- COVID-19 SARS-CoV IgG/IgM antibody rapid test
- Type of treatment
- Vaccines, Medical device
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2021to 17 Aug 2022
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any subject willing to participate since status for previous infection is not needed.
Who may be able to join
- Must be 21 years old or older.
- Must be able to provide finger stick and venous whole blood samples.
- Must be able to understand and sign a consent form.
- Must be able to provide an additional sample(s) required by the study site for an additional FDA EUA authorized antibody testing (ELISA, CMIA, or other antibody test).
- Has an immediate need to determine COVID-19 status for occupational purposes.
- Was exposed to a COVID-19 patient within 7 days that leads the healthcare provider to suspect the individual of possibly having SARS-CoV-2 infection.
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- Has symptoms that lead the healthcare provider to suspect the individual of possibly having SARS-CoV-2 infection.
- Has had a positive FDA EUA authorized PCR test between 1-28 days with or without symptom expression.
- Individuals who have tested positive for COVID-19 infection and have antibodies detected must have agreed to participate in the MCW Tissue Bank COVID-19 banking project.
Who cannot join
- Is receiving treatment with infusion of convalescent plasma or other antibody therapy related to SARS-CoV-2 infections.
- Tested negative for COVID-19 by PCR more than 7 days ago.
- Is participating in a SARS-CoV-2 vaccine study.or received any doses of the available SARS-CoV-2 vaccines.
- Previously tested positive for COVID-19 at any point in time (for asymptomatic patients enrolling in the negative patient population).
Trial locations and contacts
1 site in 1 country.
About this study
This clinical study is designed to test the efficacy of the Novir 2019-nCoV Immunoglobulin M/Immunoglobulin G Antibody Test in a point-of-care setting to support the increasing need for rapid screening in the detection of antibodies. The study is performed on individuals who have no history of COVID-19 and no history of COVID immunization as well as individuals with history of COVID-19 that was diagnosed greater than 15 days. This is performed both through 3mL venous whole blood which is ran through an assay as well a point-of-care rapid test which is resulted in 10 minutes. Aiding in the rapid detection of COVID-19 antibodies.
Read the detailed description
This clinical study is designed to test the efficacy and robustness of the Novir 2019-nCoV IgM/IgG Antibody Test (Colloidal Gold) in a point-of-care (POC) setting to support the growing need for rapid screening of patients to detect antibodies. The COVID-19 SARS-CoV IgM/IgG antibody rapid test is an immunochromatographic lateral flow assay intended for qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human venipuncture and finger stick whole blood. The COVID-19 SARS-CoV IgM/IgG antibody rapid test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. All the results will be compared to an FDA EUA authorized PCR test results and may also be compared to an FDA EUA authorized ELISA, CMIA, or other antibody test.
The study results will be used for an EUA application to the FDA.
- Conditions
- Covid19
- Being tested
- COVID-19 SARS-CoV IgG/IgM antibody rapid test
- Keywords
- covid 19, antibody, IgM, IgG
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 SARS-CoV IgG/IgM antibody rapid testDevice
Needle stick point of care and 3mL vial of blood will be collected and tested for individual without history of COVID-19 and immunization as well as a second group composed of individuals with history of COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Antigen testing in those who have history of COVID-19 | Individuals must have had history of COVID-19. Finger stick point of care test will be performed which results in 10 minutes indicating if there is detection of a control, IgG and IgM. Control line must be present for test to be considered valid. 3mL of venous whole blood will be collected from patient in which the research team will perform the SARS-CoV-2 antibody test. Receives: Device: COVID-19 SARS-CoV IgG/IgM antibody rapid test | |
| Antigen testing in those who do not have history of COVID-19 and COVID immunization | Individuals may not have history of COVID-19 and COVID immunizations in order to be eligible. Finger stick point of care test will be performed which results in 10 minutes indicating if there is detection of a control, IgG and IgM. Control line must be present for test to be considered valid. 3mL of venous whole blood will be collected from patient in which the research team will perform the SARS-CoV-2 antibody test. Receives: Device: COVID-19 SARS-CoV IgG/IgM antibody rapid test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Novir 2019-nCoV IgG/IgM Antibody test
To determine the sensitivity and specificity of the Novir 2019-nCoV IgM/IgG Antibody Test (Colloidal Gold) when testing intended use populations who meet the criteria of having COVID-19 infection by Centers for Disease Control and Prevention (CDC). The test is to be performed by healthcare professionals (non-CLIA laboratory technicians) at POC settings.vStandard calculations will be used to derive sensitivity, specificity, positive and negative predictive values as well as 95% confidence intervals compared to reference method.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start13 Apr 2021
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Why it stopped: Failed to meet FDA criteria on one target at FDA, CDC, and market is not looking for rapid antibody tests.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Novir
- Responsible party
- Principal investigator, Matthew Faron, PhD, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902911
- Sponsor's protocol ID
- PRO00039709
- Acronym
- NOVIR POC
- Status last verified
- Jan 2024
- First submitted
- 21 May 2021
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Evaluation of Novir 2019-nCoV Immunoglobulin G/ Immunoglobulin M (IgG/IgM) Antibody Test (Collodial Gold)
- ClinicalTrials.gov ID
- NCT04902911
- Acronym / sponsor ID
- NOVIR POC / PRO00039709
- Conditions
- Covid19
- Keywords
- covid 19, antibody, IgM, IgG
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Failed to meet FDA criteria on one target at FDA, CDC, and market is not looking for rapid antibody tests.
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Novir
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 26 May 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.
This clinical study is designed to test the efficacy of the Novir 2019-nCoV Immunoglobulin M/Immunoglobulin G Antibody Test in a point-of-care setting to support the increasing need for rapid screening in the detection of antibodies. The study is performed on individuals who have no history of COVID-19 and no history of COVID immunization as well as individuals with history of COVID-19 that was diagnosed greater than 15 days. This is performed both through 3mL venous whole blood which is ran through an assay as well a point-of-care rapid test which is resulted in 10 minutes. Aiding in the rapid detection of COVID-19 antibodies.
Detailed description
This clinical study is designed to test the efficacy and robustness of the Novir 2019-nCoV IgM/IgG Antibody Test (Colloidal Gold) in a point-of-care (POC) setting to support the growing need for rapid screening of patients to detect antibodies. The COVID-19 SARS-CoV IgM/IgG antibody rapid test is an immunochromatographic lateral flow assay intended for qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human venipuncture and finger stick whole blood. The COVID-19 SARS-CoV IgM/IgG antibody rapid test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. All the results will be compared to an FDA EUA authorized PCR test results and may also be compared to an FDA EUA authorized ELISA, CMIA, or other antibody test.
The study results will be used for an EUA application to the FDA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antigen testing in those who have history of COVID-19 | – | Device: COVID-19 SARS-CoV IgG/IgM antibody rapid testIndividuals must have had history of COVID-19. Finger stick point of care test will be performed which results in 10 minutes indicating if there is detection of a control, IgG and IgM. Control line must be present for test to be considered valid. 3mL of venous whole blood will be collected from patient in which the research team will perform the SARS-CoV-2 antibody test. |
| Antigen testing in those who do not have history of COVID-19 and COVID immunization | – | Device: COVID-19 SARS-CoV IgG/IgM antibody rapid testIndividuals may not have history of COVID-19 and COVID immunizations in order to be eligible. Finger stick point of care test will be performed which results in 10 minutes indicating if there is detection of a control, IgG and IgM. Control line must be present for test to be considered valid. 3mL of venous whole blood will be collected from patient in which the research team will perform the SARS-CoV-2 antibody test. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any subject willing to participate since status for previous infection is not needed.
Key inclusion criteria (9 listed)
- Must be 21 years old or older.
- Must be able to provide finger stick and venous whole blood samples.
- Must be able to understand and sign a consent form.
- Must be able to provide an additional sample(s) required by the study site for an additional FDA EUA authorized antibody testing (ELISA, CMIA, or other antibody test).
- Has an immediate need to determine COVID-19 status for occupational purposes.
Key exclusion criteria (4 listed)
- Is receiving treatment with infusion of convalescent plasma or other antibody therapy related to SARS-CoV-2 infections.
- Tested negative for COVID-19 by PCR more than 7 days ago.
- Is participating in a SARS-CoV-2 vaccine study.or received any doses of the available SARS-CoV-2 vaccines.
- Previously tested positive for COVID-19 at any point in time (for asymptomatic patients enrolling in the negative patient population).
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 |
|---|---|---|
| COVID-19 SARS-CoV IgG/IgM antibody rapid testNeedle stick point of care and 3mL vial of blood will be collected and tested for individual without history of COVID-19 and immunization as well as a second group composed of individuals with history of COVID-19 | Device | Antigen testing in those who do not have history of COVID-19 and COVID immunization, Antigen testing in those who have history of COVID-19 |
Primary outcome
Novir 2019-nCoV IgG/IgM Antibody test
Time frame: 2 years
To determine the sensitivity and specificity of the Novir 2019-nCoV IgM/IgG Antibody Test (Colloidal Gold) when testing intended use populations who meet the criteria of having COVID-19 infection by Centers for Disease Control and Prevention (CDC). The test is to be performed by healthcare professionals (non-CLIA laboratory technicians) at POC settings.vStandard calculations will be used to derive sensitivity, specificity, positive and negative predictive values as well as 95% confidence intervals compared to reference method.
Results and safety
The study was stopped early (reason given: Failed to meet FDA criteria on one target at FDA, CDC, and market is not looking for rapid antibody tests.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- 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.
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 Covid19, run by Medical College of Wisconsin 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 9 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Jan 2024. 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 stopped early (reason given: Failed to meet FDA criteria on one target at FDA, CDC, and market is not looking for rapid antibody tests.). Results are not available in the source record.
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?
Novir 2019-nCoV IgG/IgM Antibody test (time frame: 2 years). 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 8 Jan 2024.