Trials / Completed
CompletedNCT04321369
Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 530 (actual)
- Sponsor
- UnitedHealth Group · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Operational project to compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting
Detailed description
This work will serve both the Everett Clinic and broader UnitedHealth Group patient populations as well as advance the public health emergency (PHE) response to the community spread of SARS-CoV-2 virus, especially as the number of cases and deaths continues to rise in many geographies. Leveraging our presence in the Seattle/Puget Sound area with Everett Clinic, we intend to develop a model that can screen a large number of patients at varying levels of risk and manifestation of clinical symptoms while conserving personal protective equipment (PPE) and decreasing transmission risk to health care workers. This will also serve to support the enterprise and public health response. Towards this goal, we must first assess the equivalence between clinician-collected nasopharyngeal (NP) samples to patient-collected tongue, nasal, and mid-turbinate (MT) samples to detect SARS-CoV-2 across a broad cross-section of the population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals | This is an operational project. Patients will collect a sample from the tongue, nasal cavity and MT and then clinicians will collect a NP sample from the nostril corresponding to each participant's dominant hand. |
Timeline
- Start date
- 2020-03-09
- Primary completion
- 2020-03-23
- Completion
- 2020-03-23
- First posted
- 2020-03-25
- Last updated
- 2022-05-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04321369. Inclusion in this directory is not an endorsement.