N/A
Completed N=1,320
Validation of a Rapid Quantitative Test for Loss of Smell in COVID-19 Subjects
Source: ClinicalTrials.gov NCT04431908 ↗Enrolled (actual)
1,320
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Sensitivity, Specificity and Accuracy — 889; 106; 27; 20 Participants
Summary
The purpose of this study is to evaluate the performance of a non-invasive olfactory device as a rapid indicator of COVID-19 in positive subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity, Specificity and Accuracy |
889; 106; 27; 20 | — |
| SECONDARY Repeatability |
— | — |
| SECONDARY Asymptomatic Sensitivity, Specificity and Accuracy |
244; 31; 27; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Have a corresponding PCR test for SARS-CoV-2 on the same day.
Exclusion Criteria
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Individuals with allergic to fragrances
- History of surgery on the nose or paranasal sinuses
- Asthmatics
- Patients with known neurocognitive disorders: dementia, Alzheimer's disease, Parkinson's disease
- Adults with Acute or Chronic rhinosinusitis (They will be asked if they have a 'stuffy or runny nose'; they may be included in some tests, but their analysis would be segregated as they may be false positives due to allergies or a common cold or flu)
Data sourced from ClinicalTrials.gov (NCT04431908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.