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
• Interventions: Diagnostic Test: Clungene rapid test cassette

• 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

Arm && Interventions

Group	Intervention	Description
Arm A (positive for COVID-19)	Clungene rapid test cassette	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.
Arm B (negative for COVID-19)	Clungene rapid test cassette	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.

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)

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

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

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