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

Sponsor

Fadi Haddad, M.D. (Other)

Overall Status

Unknown status

CT.gov ID

NCT04402814

Collaborator

(none)

Enrollment

Locations

6.9

Anticipated Duration (Months)

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

IgG/IgM antibodies [from date of consent to date of test completion, up to 40 days]
Presence of IgG and/or IgM antibodies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fadi A. Haddad MD Inc.	La Mesa	California	United States	91942
2	Sharp Grossmont Hospital	La Mesa	California	United States	91942
3	Sharp Memorial Hosptial	San Diego	California	United States	92123

Sponsors and Collaborators

Fadi Haddad, M.D.

Investigators

Principal Investigator: Fadi Haddad, MD, Sharp HealthCare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fadi Haddad, M.D., Infectious Disease Specialist, Sharp HealthCare

ClinicalTrials.gov Identifier:

NCT04402814

Other Study ID Numbers:

IgG/IgM COVID19
2005801

First Posted:

May 27, 2020

Last Update Posted:

Jul 27, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Fadi Haddad, M.D., Infectious Disease Specialist, Sharp HealthCare

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jul 27, 2020