COVID-19 InfectionEND CoV-2NCT04513990
Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)
A study testing Biospecimen Collection and Questionnaire Administration in people with COVID-19 Infection, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Biospecimen Collection and Questionnaire Administration
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2020to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient or provider decision not to perform SARS-CoV-2 testing
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
M D Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Evaluation of a Novel Point-of-Care Diagnostic Test for SARS-CoV-2
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- COVID-19 Infection
- Being tested
- Biospecimen Collection, Questionnaire Administration
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of nasopharyngeal, oral, saliva, and nasal samples
Questionnaire AdministrationOther
Demographic information, sample collection type preferences; clinical outcome information
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (biospecimen collection) | Experimental | Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples. Receives: Procedure: Biospecimen Collection; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of diagnostic test
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.
Measured: Up to 1 year
Specificity of diagnostic test
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.
Measured: Up to 1 year
Concordance of the novel point-of-care diagnostic test
Will be estimated with 95% confidence intervals.
Measured: Up to 1 year
Positive predictive value (PPV) of the novel point-of-care diagnostic test
Will be estimated with 95% confidence intervals.
Measured: Up to 1 year
Negative predictive value (NPV) of the novel point-of-care diagnostic test
Will be estimated with 95% confidence intervals.
Measured: Up to 1 year
Secondary outcomes (2)
Viral load metrics
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.
Measured: Up to 1 month
Disease progression
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.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start9 Apr 2020
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), William Marsh Rice University
- Responsible party
- Sponsor
- Investigators
- Kathleen M Schmeler, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513990
- Sponsor's protocol ID
- 2020-0318
- Other IDs
- NCI-2020-03470, 2020-0318
- Acronym
- END CoV-2
- Status last verified
- Dec 2021
- First submitted
- 5 Jun 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Point-of-Care Diagnostic Test for SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04513990
- Acronym / sponsor ID
- END CoV-2 / 2020-0318
- Conditions
- COVID-19 Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 257 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), William Marsh Rice University
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (biospecimen collection) | Experimental | Procedure: Biospecimen Collection, Other: Questionnaire AdministrationParticipants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patient or provider decision not to perform SARS-CoV-2 testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of nasopharyngeal, oral, saliva, and nasal samples | Procedure or surgery | Diagnostic (biospecimen collection) |
| Questionnaire AdministrationDemographic information, sample collection type preferences; clinical outcome information | Other | Diagnostic (biospecimen collection) |
Primary outcome
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.
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.
Concordance of the novel point-of-care diagnostic test
Time frame: Up to 1 year
Will be estimated with 95% confidence intervals.
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.
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.
2 secondary outcomes
Viral load metrics
Time frame: Up to 1 month
Disease progression
Time frame: Up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Schmeler principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection and Questionnaire Administration in people with COVID-19 Infection, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of diagnostic test (time frame: Up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.