Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513990
Status:
UNKNOWN
Last Update Posted:
2021-12-22
First Post:
2020-06-05
Brief Title:
Novel Point-of-Care Diagnostic Test for SARS-CoV-2 COVID-19
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Evaluation of a Novel Point-of-Care Diagnostic Test for SARS-CoV-2
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
END CoV-2
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-0318 | OTHER | M D Anderson Cancer Center | None |
| NCI-2020-03470 | REGISTRY | None | None |