Skip to main content
OpenTrials
Completed

NCT Number: NCT04431908

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

olfactory device

Device

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

Primary outcomes

  1. Sensitivity, Specificity and Accuracy

    Time frame: 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 outcomes

  1. Repeatability

    Time frame: 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.

  2. Asymptomatic Sensitivity, Specificity and Accuracy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2020
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.