Status:
UNKNOWN
IgG/IgM Antibody Test in Patients Who Have Tested Negative or Positive for COVID-19 With the Standard Method of COVID19 Testing.
Lead Sponsor:
Fadi Haddad, M.D.
Conditions:
SARS-CoV 2
Eligibility:
All Genders
18+ years
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 posi...
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 posit...
Eligibility Criteria
Inclusion
- 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
- Impaired cognitive or decision-making capacity (based on the clinical judgment of the PI or designee)
Key Trial Info
Start Date :
May 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04402814
Start Date
May 5 2020
End Date
December 1 2020
Last Update
July 27 2020
Active Locations (3)
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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