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Self-sampling for the Study of COVID-19

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: NCT04447495
Recruitment Status : Not yet recruiting
First Posted : June 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Juan C. Felix, MD, Medical College of Wisconsin

Brief Summary:
This study will evaluate the feasibility of self-sampling with the iAMP® COVID-19 Detection Kit (Atila BioSystems, Mountain View, CA), a new, low-cost SARS-CoV-2 test that does not require RNA extraction. We will compare the sensitivity and specificity of the iAMP® assay on self-sampled mid-turbinate, anterior nares, and saliva swabs against the gold standard, a nucleic acid amplification testing assay on a clinician-collected nasopharyngeal swab.

Condition or disease Intervention/treatment
Coronavirus Diagnostic Test: iAMP test

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Self-sampling for the Study of COVID-19
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
SARS-CoV-2 positive
We will enroll patients within a larger clinical validation study of the iAMP® test against the gold standard (the CDC-recommended test) until we have prospectively collected a total of 100 positive cases.
Diagnostic Test: iAMP test
The low-cost Atila BioSystems iAMP® COVID-19 Detection kit consists of a reaction buffer mix, primer mix, three sample buffer components, a positive and negative control, nasopharyngeal swabs, and sample collection vials. Each kit is suitable for 100 tests.

Controls
Current SARS-CoV-2 positivity in the region is approximately 20%, therefore, approximately 400 negative control samples will be needed.
Diagnostic Test: iAMP test
The low-cost Atila BioSystems iAMP® COVID-19 Detection kit consists of a reaction buffer mix, primer mix, three sample buffer components, a positive and negative control, nasopharyngeal swabs, and sample collection vials. Each kit is suitable for 100 tests.




Primary Outcome Measures :
  1. Validate iAMP testing kit [ Time Frame: 1 month ]
    Validate the iAMP® testing kit for use in the mid-turbinate, anterior nares and with saliva collection and compare the sensitivities and specificities of each site to nasopharyngeal collection.


Biospecimen Retention:   Samples Without DNA
A dry swab will be collected from two of the three iAMP® self-sample sites - mid-turbinate and anterior nares.


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
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
SARS-CoV-2 positive participants
Criteria

Inclusion Criteria:

Patients older than 18 presenting for COVID-19 testing, able to tolerate nasopharyngeal swabs, and able to follow instructions for self-collection.

Exclusion Criteria:

Unable or unwilling to provide informed consent and/or reliable contact information.


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): NCT04447495


Contacts
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Contact: Juan Felix, M.D. 626-926-4970 jcfelix@mcw.edu

Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Juan Felix, M.D. Medical College of Wisconsin
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Responsible Party: Juan C. Felix, MD, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04447495    
Other Study ID Numbers: 20-001
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 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: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases