SARS-CoV 2NCT04402814
IgG/IgM Antibody Test in Patients Who Have Tested Negative or Positive for COVID-19 With the Standard Method of COVID19 Testing.
An observational study of SARS-CoV 2, run by Fadi Haddad, M.D. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test and correlate it with the standard method of testing in inpatients who have tested positive or negative for COVID19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV 2
- What is being tested?
- Clungene rapid test cassette
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 May 2020to 1 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized (or recently discharged) subjects who have been previously tested for COVID-19 with the standard method of testing.
Who may be able to join
- Received confirmed COVID-19 positive or negative test from Sharp HealthCare's standard method of testing.
- Age >/=18 years old.
- Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.
- Able to read/write/speak English or Spanish fluently.
- Subjects must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
- Hospitalized at the time of consent or recently discharged with leftover blood stored at hospital laboratory
Who cannot join
- Impaired cognitive or decision-making capacity (based on the clinical judgment of the PI or designee)
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Fadi A. Haddad MD Inc.
La Mesa, California, 91942
Divina Fanning, RN, 619-823-7347, divina.fanning@sharp.com
- Recruiting
Sharp Grossmont Hospital
La Mesa, California, 91942
Divina Fanning, RN, 619-823-7347, divina.fanning@sharp.com
- Recruiting
Sharp Memorial Hosptial
San Diego, California, 92123
Divina Fanning, RN, 619-823-7347, divina.fanning@sharp.com
About this study
Official title: Evaluation and Correlation of SARS-Cov2 Virus IgG/IgM Rapid Test Cassette Clungene Test With the Standard Method of COVID19 Testing in Inpatients With or Without COVID19
The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test and correlate it with the standard method of testing in inpatients who have tested positive or negative for COVID19.
Read the detailed description
This is a laboratory testing study using the SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test to determine the presence of IgM and IgG antibodies in subjects who have tested negative or positive for COVID-19. The study is observational and subjects will be assigned to one of two arms depending on the results of their nCOVID-19 test.
- Conditions
- SARS-CoV 2
- Being tested
- Clungene rapid test cassette
- Keywords
- Coronavirus, COVID-19, Clungene, IgG/IgM antibodies
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clungene rapid test cassetteDiagnostic test
Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (positive for COVID-19) | One or two samples of your blood that were previously collected for routine care will be obtained from the hospital laboratory and will be tested for the antibodies against COVID-19 virus.
* First blood sample obtained: 7 to 12 days following onset of symptoms; and/or
* Second blood sample obtained: 12 to 40 days following the onset of symptoms. Receives: Diagnostic Test: Clungene rapid test cassette | |
| Arm B (negative for COVID-19) | One sample of blood that was collected for routine care at any point during hospitalization will be obtained from the hospital laboratory and will be tested for the antibodies. Receives: Diagnostic Test: Clungene rapid test cassette |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG/IgM antibodies
Presence of IgG and/or IgM antibodies
Measured: from date of consent to date of test completion, up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start5 May 2020
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2Studies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fadi Haddad, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fadi Haddad, M.D., Sharp HealthCare
- Investigators
- Fadi Haddad, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402814
- Sponsor's protocol ID
- IgG/IgM COVID19
- Other IDs
- 2005801
- Status last verified
- Jul 2020
- First submitted
- 22 May 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- 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 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Correlation of SARS-Cov2 Virus IgG/IgM Rapid Test Cassette Clungene Test With the Standard Method of COVID19 Testing in Inpatients With or Without COVID19
- ClinicalTrials.gov ID
- NCT04402814
- Acronym / sponsor ID
- IgG/IgM COVID19
- Conditions
- SARS-CoV 2
- Keywords
- Coronavirus, COVID-19, Clungene, IgG/IgM antibodies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fadi Haddad, M.D.University, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 27 May 2020 (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 evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test and correlate it with the standard method of testing in inpatients who have tested positive or negative for COVID19.
Detailed description
This is a laboratory testing study using the SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test to determine the presence of IgM and IgG antibodies in subjects who have tested negative or positive for COVID-19. The study is observational and subjects will be assigned to one of two arms depending on the results of their nCOVID-19 test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (positive for COVID-19) | – | Diagnostic Test: Clungene rapid test cassetteOne or two samples of your blood that were previously collected for routine care will be obtained from the hospital laboratory and will be tested for the antibodies against COVID-19 virus. * First blood sample obtained: 7 to 12 days following onset of symptoms; and/or * Second blood sample obtained: 12 to 40 days following the onset of symptoms. |
| Arm B (negative for COVID-19) | – | Diagnostic Test: Clungene rapid test cassetteOne sample of blood that was collected for routine care at any point during hospitalization will be obtained from the hospital laboratory and will be tested for the antibodies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized (or recently discharged) subjects who have been previously tested for COVID-19 with the standard method of testing.
Key inclusion criteria (6 listed)
- Received confirmed COVID-19 positive or negative test from Sharp HealthCare's standard method of testing.
- Age >/=18 years old.
- Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.
- Able to read/write/speak English or Spanish fluently.
- Subjects must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
Key exclusion criteria (1 listed)
- Impaired cognitive or decision-making capacity (based on the clinical judgment of the PI or designee)
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 |
|---|---|---|
| Clungene rapid test cassetteBlood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette. | Diagnostic test | Arm A (positive for COVID-19), Arm B (negative for COVID-19) |
Primary outcome
IgG/IgM antibodies
Time frame: from date of consent to date of test completion, up to 40 days
Presence of IgG and/or IgM antibodies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- 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.
Fadi Haddad, MD principal investigator
Sharp HealthCare
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, run by Fadi Haddad, M.D. 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 6 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: status not confirmed, as of the sponsor's last update on 27 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Miller (858-939-7162, kathryn.miller@sharp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG/IgM antibodies (time frame: from date of consent to date of test completion, up to 40 days). 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 2020.