COVID-19 Infection
Conditions
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.
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of nasopharyngeal, oral, saliva, and nasal samples
OTHERQuestionnaire Administration
Demographic information, sample collection type preferences; clinical outcome information
Sponsors
National Cancer Institute (NCI)
William Marsh Rice University
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value (PPV) of the novel point-of-care diagnostic test | Up to 1 year | Will be estimated with 95% confidence intervals. |
| Sensitivity of diagnostic test | 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. |
| Specificity of diagnostic test | 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. |
| Concordance of the novel point-of-care diagnostic test | Up to 1 year | Will be estimated with 95% confidence intervals. |
| Negative predictive value (NPV) of the novel point-of-care diagnostic test | Up to 1 year | Will be estimated with 95% confidence intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression | 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. |
| Viral load metrics | 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. |
Countries
United States
Outcome results
None listed