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

SARS-CoV 2 Clinical Trial

Official title:

Evaluation and Correlation of SARS-Cov2 Virus IgG/IgM Rapid Test Cassette Clungene Test With the Standard Method of COVID19 Testing in Inpatients With or Without COVID19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402814
• Other study ID #: IgG/IgM COVID19
• Secondary ID: 2005801
• Status: Recruiting
• Start date: May 5, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2020
• Source: Sharp HealthCare
• Contact: Kathryn Miller
• Phone: 858-939-7162
• Email: kathryn.miller[@]sharp.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• SARS-CoV 2

Intervention

Diagnostic Test:
• Clungene rapid test cassette
Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.

Locations

Country	Name	City	State
United States	Fadi A. Haddad MD Inc.	La Mesa	California
United States	Sharp Grossmont Hospital	La Mesa	California
United States	Sharp Memorial Hosptial	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Fadi Haddad, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgG/IgM antibodies	Presence of IgG and/or IgM antibodies	from date of consent to date of test completion, up to 40 days