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

Completed

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
High Risk Asymptomatics	olfactory device	Asymptomatic patients (residents) in a high risk location.
Outpatients (Drive Thru)	olfactory device	Patients receiving testing through a drive thru location.

Primary Outcome Measures

Name	Time	Method
Sensitivity, Specificity and Accuracy	24 hours	The subject's score on using the olfactory device will be compared to the PCR results (SARS-CoV-2 negative or positive) on COVID19 outpatients. As the smell test has a variable scale (0-5) the ideal cutoff will be determined to maximize these factors: * Sensitivity (Represents True Positives Divided by True Positives plus False Negatives) * Specificity (Represents True Negatives Divided by True Negatives plus False Positives) * Accuracy (Represents Sensitivity x Prevalence + Specificity x (1-Prevalence) True Positives are patients who got 3 or less correct answers on the smell test and had a positive PCR COVID test. True Negatives are patients who got 4 or 5 correct responses on the smell test and had a negative PCR COVID test. False Positives are patients who got 3 or less correct responses on the smell test and had a negative PCR COVID test. False Negatives are patients who got 4 or 5 correct responses on the smell test and had a positive PCR COVID test.

Secondary Outcome Measures

Name	Time	Method
Asymptomatic Sensitivity, Specificity and Accuracy	24 hours	We will determine if 'asymptomatic' SARS-CoV-2 positive subjects experience a partial loss of smell (hyposmia) and if so determine the fraction of subjects in which this occurs. We will evaluate sensitivity, specificity and accuracy. Sensitivity (Represents True Positives Divided by True Positives plus False Negatives) * Specificity (Represents True Negatives Divided by True Negatives plus False Positives) * Accuracy (Represents Sensitivity x Prevalence + Specificity x (1-Prevalence) True Positives are patients who got 3 or less correct answers on the smell test and had a positive PCR COVID test. True Negatives are patients who got 4 or 5 correct responses on the smell test and had a negative PCR COVID test. False Positives are patients who got 3 or less correct responses on the smell test and had a negative PCR COVID test. False Negatives are patients who got 4 or 5 correct responses on the smell test and had a positive PCR COVID test.
Repeatability	48 hours	Repeatability will also be examined in a test-retest score conducted within 24 hours with a second device in which the sequence of the odorants is altered.

Locations (1): Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States