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

NCT04431908 | Completed Results DMC

• 1 other identifier: 2000028259
• Study Type: observational
• Target: 1,320
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

olfactory device; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Repeatability

  48 hours

• Asymptomatic Sensitivity, Specificity and Accuracy

  24 hours

Study Arms (2)

Outpatients (Drive Thru)

Patients receiving testing through a drive thru location.

Device: olfactory device

High Risk Asymptomatics

Asymptomatic patients (residents) in a high risk location.

Device: olfactory device

Interventions

olfactory device DEVICE

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

High Risk Asymptomatics; Outpatients (Drive Thru)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• 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.

  PMID: 35151176 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

It is possible that the PCR COVID test results were incorrect, as these tests are not 100% accurate.

Results Point of Contact

• Title: Dr. R. Peter Manes
• Organization: Yale School of Medicine

rpeter.manes@yale.edu

(203) 785-5430

Study Officials

• R Peter Manes, MD, FACS

  Associate Professor of Surgery (Otolaryngology)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: June 15, 2020
• Primary Completion: October 15, 2020
• Study Completion: November 18, 2020
• Last Updated: June 2, 2021
• Results First Posted: June 2, 2021

Record last verified: 2021-05

Locations

US (1)