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UNKNOWNNCT04402814

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

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 posi...

Lead sponsor: Fadi Haddad, M.D.•3 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Kathryn Miller

CONTACT

858-939-7162 kathryn.miller@sharp.com

Divina Fanning, RN

CONTACT

(619)823-7347 divina.fanning@sharp.com

Sponsors

Lead Sponsor

Fadi Haddad, M.D.

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 27, 2020Terms

Trial snapshot

StatusUNKNOWN

Phase—

Enrollment90

Start dateMay 2020

Last updatedJul 27, 2020

Condition

Locations shown

Fadi A. Haddad MD Inc.

La Mesa, California

Sharp Grossmont Hospital

La Mesa, California

Sharp Memorial Hosptial

San Diego, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2020Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions