Clinical trial NCT04431908: Validation of a Rapid Quantitative Test for Loss of Smell in COVID-19 Subjects
Official title: Validation of a Rapid Quantitative Test for Loss of Smell in COVID-19 Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: olfactory device
COVID-19
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 1320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be either individuals receiving drive-thru COVID-19 testing or residents of a nursing facility receiving tests.

Brief 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.

Detailed description: The major hypothesis is that a quantitative and unbiased smell test will be a useful tool to identify COVID-19 positive individuals.

The study will address what fraction of outpatients truly have a loss-of-smell (including a partial loss) and is expected to outperform the current question that is used to identify COVID-19 related anosmia "Do you have a new loss of smell or taste?" (yes/no) in terms of sensitivity and specificity.

The study will address if high-risk asymptomatic people whom are SARS-CoV-2 positive have a partial (or perhaps transitory) loss of smell.

The primary objective of this study is to validate the utility (sensitivity, specificity and accuracy) of a quantitative non-biased olfactory device for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR). The performance of the device will also be compared to the standard CDC patient query for 'new loss of smell or taste'.

The secondary objective is to test if SARS-CoV-2 positive 'asymptomatic' COVID-19 subjects may actually present with a mild or transitory defect in smell (hyposmia), which is revealed through our quantitative olfactory smell test.

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)

Primary outcomes:
measure: Sensitivity, Specificity and Accuracy
timeFrame: 24 hours
Secondary outcomes:
measure: Repeatability
timeFrame: 48 hours
measure: Asymptomatic Sensitivity, Specificity and Accuracy
timeFrame: 24 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Associate Professor of Surgery (Otolaryngology)
name: R Peter Manes, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel RA, Torabi SJ, Kasle DA, Manes RP. Five-item odorant test as an indicator of COVID-19 infection in a general population. Am J Otolaryngol. 2022 Mar-Apr;43(2):103376. doi: 10.1016/j.amjoto.2022.103376. Epub 2022 Jan 29.