Validation of a Rapid Quantitative Test for Loss of Smell in COVID-19 Subjects

Yale University

Status

Completed

Conditions

COVID-19

Treatments

Device: olfactory device

Study type

Observational

Funder types

Other

Identifiers

NCT04431908

2000028259

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,320 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)