Recruiting

Antibody Test

Sponsor:

Fadi Haddad, M.D.

Code:

NCT04402814

Conditions

SARS-CoV 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clungene rapid test cassette

Study Details

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.

Conditions

SARS-CoV 2

Study ID

NCT04402814

Start date

May 5, 2020

Status verified date

Jul, 2020

Completion date

Dec 1, 2020

Anticipated

Primary completion date

Oct 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Clungene rapid test cassette

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

Primary outcome measure

  • IgG/IgM antibodies [ Time Frame: from date of consent to date of test completion, up to 40 days ]

Central Contacts and Locations

Central contacts

Kathryn Miller

858-939-7162kathryn.miller@sharp.com

Divina Fanning, RN

(619)823-7347divina.fanning@sharp.com

Locations

Fadi A. Haddad MD Inc.

Recruiting

La Mesa, California, United States, 91942

Contacts

Divina Fanning, RN

619-823-7347divina.fanning@sharp.com

Sharp Grossmont Hospital

Recruiting

La Mesa, California, United States, 91942

Contacts

Divina Fanning, RN

619-823-7347divina.fanning@sharp.com

Sharp Memorial Hosptial

Recruiting

San Diego, California, United States, 92123

Contacts

Divina Fanning, RN

619-823-7347divina.fanning@sharp.com

More Information

Sponsor

Fadi Haddad, M.D.

Last update posted

Jul 27, 2020

Last verified

Jul, 2020

Keywords

  • Coronavirus
  • COVID-19
  • Clungene
  • IgG/IgM antibodies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fadi Haddad, M.D. on 2020-07-27.