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

• Conditions: SARS-CoV 2

• Registration Number: NCT04402814
• Lead Sponsor: Fadi Haddad, M.D.

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.

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 Timeline

• Study Start: 2020-05-05
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-27
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IgG/IgM antibodies	from date of consent to date of test completion, up to 40 days	Presence of IgG and/or IgM antibodies

Trial Locations

Locations (3)

Fadi A. Haddad MD Inc.; 🇺🇸 La Mesa, California, United States

Sharp Grossmont Hospital; 🇺🇸 La Mesa, California, United States

Sharp Memorial Hosptial; 🇺🇸 San Diego, California, United States