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
2 other identifiers
observational
90
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2020
CompletedFirst Submitted
Initial submission to the registry
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 27, 2020
July 1, 2020
5 months
May 22, 2020
July 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IgG/IgM antibodies
Presence of IgG and/or IgM antibodies
from date of consent to date of test completion, up to 40 days
Study Arms (2)
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
Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.
Eligibility Criteria
Hospitalized (or recently discharged) subjects who have been previously tested for COVID-19 with the standard method of testing.
You may qualify if:
- 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
You may not qualify if:
- Impaired cognitive or decision-making capacity (based on the clinical judgment of the PI or designee)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Fadi A. Haddad MD Inc.
La Mesa, California, 91942, United States
Sharp Grossmont Hospital
La Mesa, California, 91942, United States
Sharp Memorial Hosptial
San Diego, California, 92123, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fadi Haddad, MD
Sharp HealthCare
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Infectious Disease Specialist
Study Record Dates
First Submitted
May 22, 2020
First Posted
May 27, 2020
Study Start
May 5, 2020
Primary Completion
October 1, 2020
Study Completion
December 1, 2020
Last Updated
July 27, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share