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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431908
• Other study ID #: 2000028259
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: November 18, 2020

Study information

• Verified date: May 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1320
• Est. completion date: November 18, 2020
• Est. primary completion date: October 15, 2020
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• olfactory device
A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR).

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, Specificity and Accuracy	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.	24 hours
Secondary	Repeatability	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.	48 hours
Secondary	Asymptomatic Sensitivity, Specificity and Accuracy	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.	24 hours