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Rapid SARS-CoV-2 IgG Antibody Testing in High Risk Healthcare Workers (COVID-Antibody)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334876
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Courtney Rowan, Indiana University

Brief Summary:
The purpose of this study is to validate the use of a rapid, at home, point-of-care (POC) SARS-CoV-2 IgG antibody test in high risk healthcare workers. Additionally, we would like to evaluate the incidence of seroconversion in this high-risk population and to identify possible candidates for convalescent plasma donation for therapy/prophylaxis.

Condition or disease Intervention/treatment
SARS-CoV-2 Diagnostic Test: SARS-CoV-2 IgG Antibody Testing Kit

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Study Type : Observational
Estimated Enrollment : 340 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Rapid SARS-CoV-2 IgG Antibody Testing in High Risk Healthcare Workers and Candidacy for Convalescent Plasma Therapy/Prophylaxis
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
High Risk Healthcare Workers
At home, finger prick, antibody test.
Diagnostic Test: SARS-CoV-2 IgG Antibody Testing Kit
A, finger prick, at home test for SARS-CoV-2 IgG Antibodies.
Other Name: Ray Biotech




Primary Outcome Measures :
  1. Validation of SARS-CoV-2 IgG Antibody Test [ Time Frame: April 2020-January 2021 ]
    To validate the use of a rapid, at home, point-of-care (POC) SARS-CoV-2 IgG antibody test in high risk healthcare workers


Secondary Outcome Measures :
  1. Incidence of Seroconversion [ Time Frame: April 2020-January 2021 ]
    To evaluate the incidence of seroconversion in this high-risk population

  2. Identify Candidacy [ Time Frame: April 2020-January 2021 ]
    To identify possible candidates for convalescent plasma donation for therapy/prophylaxis (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
High risk healthcare workers
Criteria

Inclusion Criteria:

  1. High risk healthcare workers, prioritizing those who are exposed to aerosol generating procedures (physicians and respiratory therapist) working in the emergency room or intensive care units at Indiana University Health or IU school of Medicine affiliated facilities. A second tier of prioritization, to be approached if testing capacity remains after the initial testing phase, will be nurses working these same areas
  2. Health care workers who are currently out sick or quarantined due to possible/known exposure to COVID-19 and whose physician confirms that a negative test would allow their return to work are also eligible for testing (Subjects in this group may begin study procedures and be registered once they reach the end of their quarantine period)

Exclusion Criteria:

1. Previously tested for COVID-19


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334876


Contacts
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Contact: Courtney Rowan, MD 3179441363 coujohns@iu.edu
Contact: Kirsten Ramberg 3179482816 kramberg@iu.edu

Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Courtney Rowan, MD Indiana University
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Responsible Party: Courtney Rowan, MD, Indiana University
ClinicalTrials.gov Identifier: NCT04334876    
Other Study ID Numbers: 2003973826
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antibodies
Immunologic Factors
Physiological Effects of Drugs