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

Last updated: July 23, 2020
Sponsor: Fadi Haddad, M.D.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04402814
IgG/IgM COVID19
2005801
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Received confirmed COVID-19 positive or negative test from Sharp HealthCare's standardmethod of testing.

  • Age >/=18 years old.

  • Access to a phone in the hospital room or an electronic device that is capable ofreceiving 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, provideinformed consent, and provide authorization of use and disclosure of personal healthinformation.

  • Hospitalized at the time of consent or recently discharged with leftover blood storedat hospital laboratory

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 90
Study Start date:
May 05, 2020
Estimated Completion Date:
December 01, 2020

Study 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.

Connect with a study center

  • Fadi A. Haddad MD Inc.

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Sharp Grossmont Hospital

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Sharp Memorial Hosptial

    San Diego, California 92123
    United States

    Active - Recruiting

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