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Trial record 1 of 107 for:    IgG/IgM COVID19
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IgG/IgM Antibody Test in Patients Who Have Tested Negative or Positive for COVID-19 With the Standard Method of COVID19 Testing.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04402814
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Fadi Haddad, M.D., Sharp HealthCare

Brief 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.

Condition or disease Intervention/treatment
SARS-CoV 2 Diagnostic Test: Clungene rapid test cassette

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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 5, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 1, 2020

Group/Cohort Intervention/treatment
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.
Diagnostic Test: Clungene rapid test cassette
Blood will be tested for the presence of IgG and IgM antibodies using the 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.
Diagnostic Test: Clungene rapid test cassette
Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized (or recently discharged) subjects who have been previously tested for COVID-19 with the standard method of testing.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Impaired cognitive or decision-making capacity (based on the clinical judgment of the PI or designee)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402814


Contacts
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Contact: Kathryn Miller 858-939-7162 kathryn.miller@sharp.com
Contact: Divina Fanning, RN (619)823-7347 divina.fanning@sharp.com

Locations
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United States, California
Fadi A. Haddad MD Inc. Recruiting
La Mesa, California, United States, 91942
Contact: Divina Fanning, RN    619-823-7347    divina.fanning@sharp.com   
Sharp Grossmont Hospital Recruiting
La Mesa, California, United States, 91942
Contact: Divina Fanning, RN    619-823-7347    divina.fanning@sharp.com   
Sharp Memorial Hosptial Recruiting
San Diego, California, United States, 92123
Contact: Divina Fanning, RN    619-823-7347    divina.fanning@sharp.com   
Sponsors and Collaborators
Fadi Haddad, M.D.
Investigators
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Principal Investigator: Fadi Haddad, MD Sharp HealthCare
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Responsible Party: Fadi Haddad, M.D., Infectious Disease Specialist, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT04402814    
Other Study ID Numbers: IgG/IgM COVID19
2005801 ( Other Identifier: Sharp HealthCare Institutional Review Board (SHC IRB) )
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fadi Haddad, M.D., Sharp HealthCare:
Coronavirus
COVID-19
Clungene
IgG/IgM antibodies