- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04431908
Validation of a Rapid Quantitative Test for Loss of Smell in COVID-19 Subjects
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06519
- Yale New Haven Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Outpatients (Drive Thru)
Patients receiving testing through a drive thru location.
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A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR).
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High Risk Asymptomatics
Asymptomatic patients (residents) in a high risk location.
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A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity, Specificity and Accuracy
Time Frame: 24 hours
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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:
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Repeatability
Time Frame: 48 hours
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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.
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48 hours
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Asymptomatic Sensitivity, Specificity and Accuracy
Time Frame: 24 hours
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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)
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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: R Peter Manes, MD, FACS, Associate Professor of Surgery (Otolaryngology)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neurologic Manifestations
- Sensation Disorders
- Olfaction Disorders
- COVID-19
- Anosmia
Other Study ID Numbers
- 2000028259
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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