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

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

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.

Study Overview

• Status: Unknown
• Conditions: SARS-CoV 2
• Intervention / Treatment: Diagnostic test: Clungene rapid test cassette

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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• United States
  • California
    • La Mesa, California, United States, 91942
      • Recruiting
      • Fadi A. Haddad MD Inc.
      • Contact: Divina Fanning, RN; Phone Number: 619-823-7347; Email: divina.fanning@sharp.com
    • La Mesa, California, United States, 91942
      • Recruiting
      • Sharp Grossmont Hospital
      • Contact: Divina Fanning, RN; Phone Number: 619-823-7347; Email: divina.fanning@sharp.com
    • San Diego, California, United States, 92123
      • Recruiting
      • Sharp Memorial Hosptial
      • Contact: Divina Fanning, RN; Phone Number: 619-823-7347; Email: divina.fanning@sharp.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized (or recently discharged) subjects who have been previously tested for COVID-19 with the standard method of testing.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm A (positive for COVID-19); 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.	Diagnostic test: Clungene rapid test cassette; Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.
Arm B (negative for COVID-19); 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.	Diagnostic test: Clungene rapid test cassette; Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IgG/IgM antibodies	Presence of IgG and/or IgM antibodies	from date of consent to date of test completion, up to 40 days

Collaborators and Investigators

• Sponsor: Fadi Haddad, M.D.
• Investigators: Principal Investigator: Fadi Haddad, MD, Sharp HealthCare

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2020
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; Clungene; IgG/IgM antibodies
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IgG/IgM COVID19; 2005801 (OTHER: Sharp HealthCare Institutional Review Board (SHC IRB))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No