Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19) (END CoV-2)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04513990
Recruitment Status : Active, not recruiting
First Posted : August 14, 2020
Last Update Posted : December 22, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
William Marsh Rice University
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Infection Procedure: Biospecimen Collection Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVE:

I. To evaluate the clinical performance of a novel point-of-care diagnostic test for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes the disease called coronavirus disease 19 (COVID-19).

SECONDARY OBJECTIVES:

I. To compare the clinical performance of provider-collected nasopharyngeal samples with self-collected nasal swab, cheek swab, and saliva sample using the novel SARS-CoV-2 diagnostic test.

II. To measure viral load and evaluate the role of viral load in COVID-19 severity.

OUTLINE:

Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples.

After completion of study, participants are followed up at 1 month.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of a Novel Point-of-Care Diagnostic Test for SARS-CoV-2
Actual Study Start Date : April 9, 2020
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Diagnostic (biospecimen collection)
Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples.
 Procedure: Biospecimen Collection
Undergo collection of nasopharyngeal, oral, saliva, and nasal samples

Other: Questionnaire Administration
Demographic information, sample collection type preferences; clinical outcome information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sensitivity of diagnostic test [ Time Frame: Up to 1 year ]
    Will use the standard-of-care (real time polymerase chain reaction [RT-PCR]) coronavirus disease 19 (COVID-19) test at the MD Anderson Molecular Diagnostic Lab result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as the true result to estimate sensitivity with 95% confidence intervals. Estimates of sensitivity and specificity of the novel point-of-care diagnostic test will be provided separately for the provider-collected nasopharyngeal samples, the self-collected nasal swab, and the self-collected cheek swab.

  2. Specificity of diagnostic test [ Time Frame: Up to 1 year ]
    Will use the standard-of-care (RT-PCR) COVID-19 test at the MD Anderson Molecular Diagnostic Lab result for SARS-CoV-2 as the true result to estimate specificity with 95% confidence intervals. Estimates of sensitivity and specificity of the novel point-of-care diagnostic test will be provided separately for the provider-collected nasopharyngeal samples, the self-collected nasal swab, and the self-collected cheek swab.

  3. Concordance of the novel point-of-care diagnostic test [ Time Frame: Up to 1 year ]
    Will be estimated with 95% confidence intervals.

  4. Positive predictive value (PPV) of the novel point-of-care diagnostic test [ Time Frame: Up to 1 year ]
    Will be estimated with 95% confidence intervals.

  5. Negative predictive value (NPV) of the novel point-of-care diagnostic test [ Time Frame: Up to 1 year ]
    Will be estimated with 95% confidence intervals.


Secondary Outcome Measures :
  1. Viral load metrics [ Time Frame: Up to 1 month ]
    Will use descriptive statistics to summarize viral load metrics from the standard-of-care (RT-PCR) SARS-CoV-2 test and from each of the point-of-care tests.

  2. Disease progression [ Time Frame: Up to 1 month ]
    Will use logistic regression methods to model progression to severe disease (defined as hospitalization) as a function of viral load, age, gender, smoking history, comorbidities, and symptoms for each of these tests.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Qualifies for SARS-CoV-2 testing at MD Anderson, Lyndon B. Johnson (LBJ) hospital, or affiliated sites (may include MD Anderson and LBJ patients and employees) according to institutional criteria at time of enrollment
  • Willing and able to provide informed consent
  • Ability to perform protocol-required activities
  • Able to speak and read English or Spanish

Exclusion Criteria:

  • Patient or provider decision not to perform SARS-CoV-2 testing
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More 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): NCT04513990


Locations
Layout table for location information
United States, Texas
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77026-1967
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
William Marsh Rice University
Investigators
Layout table for investigator information
Principal Investigator: Kathleen M Schmeler M.D. Anderson Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04513990    
Other Study ID Numbers: 2020-0318
NCI-2020-03470 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0318 ( Other Identifier: M D Anderson Cancer Center )
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases