SARS-CoV2 InfectionNCT05338762
TekiTrust Tests to Determine the Level of SARS-COV-2/COVID-19 Neutralizing Antibodies in the Blood
An observational study of SARS-CoV2 Infection, run by MiCo BioMed Co., Ltd. at 5 sites in United States.
Trial summary
The purpose of this study is to determine if the TekiTrust Enzyme-Linked Immunosorbent Assay (ELISA) Kit and TekiTrust Rapid Test can accurately determine the amount of antibodies to fight the COVID-19 virus in sampled blood compared to the standard Plaque Reduction Neutralization Test (PRNT) test. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- How many people
- 218 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Jun 2021to 3 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Participants who have been previously diagnosed with SARS-CoV-2 through any FDA Emergency Use Authorization (EUA) approved assays with symptom onset within the previous 30 days or who are suspected of SARS-CoV-2 infection and are tested with FDA EUA approved RT-PCR. 2. Participants who have previously been diagnosed with SARS-CoV-2 through an FDA EUA approved RT-PCR assay with recorded symptom onset date more than 30 days, from date of PCR sample collection.
Who may be able to join
- ≥ 18 years of age
- Able and willing to provide written informed consent
- Previously diagnosed as SARS-CoV-2 positive by any FDA EUA approved assay with a symptom onset date within the previous 30 days and who are willing to provide a nasopharyngeal swab for RT-PCR testing
- Suspected of previous SARS-CoV-2 infection and willing to provide a nasopharyngeal swab for RT-PCR testing
- Previously diagnosed as SARS-CoV-2 positive by a FDA EUA approved RT-PCR assay with a symptom onset date greater than 30 days and a known date of PCR sample collection and symptom severity
Who cannot join
- 1. Any significant medical, psychological, or social condition which in the opinion of the investigator may preclude the subject from participating in the trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
WellNow Urgent Care
Cincinnati, Ohio, 45215
WellNow Urgent Care
Columbus, Ohio, 43214
WellNow Urgent Care
Dayton, Ohio, 45424
Joy Internal Medicine
Englewood Cliffs, New Jersey, 07632
Mississippi State University
Starkville, Mississippi, 39762
About this study
Official title: Clinical Agreement Study of 'TekiTrustTM SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit' and 'TekiTrustTM SARS-CoV-2 Neutralizing Antibody Detection Rapid Test'
The purpose of this study is to determine if the TekiTrust Enzyme-Linked Immunosorbent Assay (ELISA) Kit and TekiTrust Rapid Test can accurately determine the amount of antibodies to fight the COVID-19 virus in sampled blood compared to the standard Plaque Reduction Neutralization Test (PRNT) test.
When a person has COVID-19 they develop antibodies to the virus which are contained in their blood stream. After a certain period, the number of antibodies to fight (neutralize) the virus begin to decrease. One common way to measure the amount of antibodies in the blood is to use a test called the PRNT. The focus of this study is to compare the ability of the TekiTrust ELISA Kit and the TekiTrust Rapid Test with the PRNT to determine if these tests can measure the antibodies equally well.
Read the detailed description
Participants who have been previously diagnosed with COVID-19 within the past 3 months through any FDA emergency use approved (EUA) assay test will eligible for inclusion in the study. A blood and fingerstick sample will be obtained from the participant and for subjects with a positive test and symptom onset of less than 30 days a repeat RT-PCR nasal pharyngeal swab sample will be taken. The fingerstick sample will be used onsite by qualified site staff to test the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test. These results will be compared to the whole blood sample sent to the lab which will be analysed for SARS CoV-2 neutralizing antibodies using the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit and the comparator Plaque Reduction Neutralization Test (PRNT) test.
- Conditions
- SARS-CoV2 Infection
- Keywords
- Antibodies, Neutralizing, 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 |
|---|---|---|
| Current COVID-19 symptoms or SARS-CoV-2 in the last 30 days with a positive RT-PCR test | 75 subjects will be enrolled who were diagnosed as SARS-CoV-2 with a positive RT-PCR nasal pharangeal test or are suspected of having a COVID-19 infection with symptom onset in the last 30 days. (Symptom onset 0-30 days) This group of subjects will receive: 1. a fingerstick blood sample for a rapid test neutralizing antibody test to be done in the office with the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test 2. a blood draw which will be sent to the lab for neutralizing antibody testing with the TekiTrust SARS-CoV-2 Nuetralizing Antibody Detection ELISA Kit and the standard Plaque Reduction Neutralization Test (PRNT) 3. a nasal-pharangeal RT-PCR test | |
| Diagnosed with SARS-CoV-2 (COVID-19) in the past 3 months with a positive RT-PCR test | 30 subjects will be enrolled who have been diagnosed with COVID-19 in the past 3 months and had a prior positive RT-PCR nasal pharangeal test. (Symptom onsent 31-90 days) This group of subjects will receive: 1. a fingerstick blood sample for a rapid test neutralizing antibody test to be done in the office with the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test 2. a blood draw which will be sent to the lab for neutralizing antibody testing with the TekiTrust SARS-CoV-2 Nuetralizing Antibody Detection ELISA Kit and the standard Plaque Reduction Neutralization Test (PRNT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical agreement between TekiTrust SARS-CoV-2 Neutralizing Antibody ELISA Kit and Rapid Detection test and the comparator PRNT assay.
- PPA (Sensitivity) between ≥87% with a lower bound of the 95% confidence interval greater than 74.4%
- NPA (Specificity) ≥ 93% with a lower bound of the 95% confidence interval greater than 87.8%
Measured: Day one
Secondary outcomes (1)
Safety endpoint: adverse events
Number of adverse events related to blood sample testing in tested participants.
Measured: Single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start2 Jun 2021
- Primary completion15 Nov 2021
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiCo BioMed Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Responsible party
- Sponsor
- Investigators
- Jay Hahn, PhD, Study director, MiCo BioMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338762
- Sponsor's protocol ID
- MIC-US-2021-001
- Status last verified
- Aug 2022
- First submitted
- 2 Jun 2021
- Last updated
- 11 Aug 2022
- 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 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Agreement Study of 'TekiTrustTM SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit' and 'TekiTrustTM SARS-CoV-2 Neutralizing Antibody Detection Rapid Test'
- ClinicalTrials.gov ID
- NCT05338762
- Acronym / sponsor ID
- MIC-US-2021-001
- Conditions
- SARS-CoV2 Infection
- Keywords
- Antibodies, Neutralizing, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- MiCo BioMed Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 21 Apr 2022 (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 determine if the TekiTrust Enzyme-Linked Immunosorbent Assay (ELISA) Kit and TekiTrust Rapid Test can accurately determine the amount of antibodies to fight the COVID-19 virus in sampled blood compared to the standard Plaque Reduction Neutralization Test (PRNT) test.
When a person has COVID-19 they develop antibodies to the virus which are contained in their blood stream. After a certain period, the number of antibodies to fight (neutralize) the virus begin to decrease. One common way to measure the amount of antibodies in the blood is to use a test called the PRNT. The focus of this study is to compare the ability of the TekiTrust ELISA Kit and the TekiTrust Rapid Test with the PRNT to determine if these tests can measure the antibodies equally well.
Detailed description
Participants who have been previously diagnosed with COVID-19 within the past 3 months through any FDA emergency use approved (EUA) assay test will eligible for inclusion in the study. A blood and fingerstick sample will be obtained from the participant and for subjects with a positive test and symptom onset of less than 30 days a repeat RT-PCR nasal pharyngeal swab sample will be taken. The fingerstick sample will be used onsite by qualified site staff to test the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test. These results will be compared to the whole blood sample sent to the lab which will be analysed for SARS CoV-2 neutralizing antibodies using the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit and the comparator Plaque Reduction Neutralization Test (PRNT) test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current COVID-19 symptoms or SARS-CoV-2 in the last 30 days with a positive RT-PCR test | – | –75 subjects will be enrolled who were diagnosed as SARS-CoV-2 with a positive RT-PCR nasal pharangeal test or are suspected of having a COVID-19 infection with symptom onset in the last 30 days. (Symptom onset 0-30 days) This group of subjects will receive: 1. a fingerstick blood sample for a rapid test neutralizing antibody test to be done in the office with the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test 2. a blood draw which will be sent to the lab for neutralizing antibody testing with the TekiTrust SARS-CoV-2 Nuetralizing Antibody Detection ELISA Kit and the standard Plaque Reduction Neutralization Test (PRNT) 3. a nasal-pharangeal RT-PCR test |
| Diagnosed with SARS-CoV-2 (COVID-19) in the past 3 months with a positive RT-PCR test | – | –30 subjects will be enrolled who have been diagnosed with COVID-19 in the past 3 months and had a prior positive RT-PCR nasal pharangeal test. (Symptom onsent 31-90 days) This group of subjects will receive: 1. a fingerstick blood sample for a rapid test neutralizing antibody test to be done in the office with the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test 2. a blood draw which will be sent to the lab for neutralizing antibody testing with the TekiTrust SARS-CoV-2 Nuetralizing Antibody Detection ELISA Kit and the standard Plaque Reduction Neutralization Test (PRNT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Participants who have been previously diagnosed with SARS-CoV-2 through any FDA Emergency Use Authorization (EUA) approved assays with symptom onset within the previous 30 days or who are suspected of SARS-CoV-2 infection and are tested with FDA EUA approved RT-PCR. 2. Participants who have previously been diagnosed with SARS-CoV-2 through an FDA EUA approved RT-PCR assay with recorded symptom onset date more than 30 days, from date of PCR sample collection.
Key inclusion criteria (5 listed)
- ≥ 18 years of age
- Able and willing to provide written informed consent
- Previously diagnosed as SARS-CoV-2 positive by any FDA EUA approved assay with a symptom onset date within the previous 30 days and who are willing to provide a nasopharyngeal swab for RT-PCR testing
- Suspected of previous SARS-CoV-2 infection and willing to provide a nasopharyngeal swab for RT-PCR testing
- Previously diagnosed as SARS-CoV-2 positive by a FDA EUA approved RT-PCR assay with a symptom onset date greater than 30 days and a known date of PCR sample collection and symptom severity
Key exclusion criteria (1 listed)
- 1. Any significant medical, psychological, or social condition which in the opinion of the investigator may preclude the subject from participating in the trial
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
Clinical agreement between TekiTrust SARS-CoV-2 Neutralizing Antibody ELISA Kit and Rapid Detection test and the comparator PRNT assay.
Time frame: Day one
1. PPA (Sensitivity) between ≥87% with a lower bound of the 95% confidence interval greater than 74.4% 2. NPA (Specificity) ≥ 93% with a lower bound of the 95% confidence interval greater than 87.8%
1 secondary outcome
Safety endpoint: adverse events
Time frame: Single study visit
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 11 Aug 2022.
- 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.
Jay Hahn, PhD study director
MiCo BioMed
5 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-CoV2 Infection, run by MiCo BioMed Co., Ltd. at 5 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 1 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 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Clinical agreement between TekiTrust SARS-CoV-2 Neutralizing Antibody ELISA Kit and Rapid Detection test and the comparator PRNT assay. (time frame: Day one). 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 11 Aug 2022.