COVID-19NCT04431908
Validation of a Rapid Quantitative Test for Loss of Smell in COVID-19 Subjects
An observational study of COVID-19, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- olfactory device
- Type of treatment
- Medical device
- How many people
- 1,320 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 18 Nov 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The population will be either individuals receiving drive-thru COVID-19 testing or residents of a nursing facility receiving tests.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06519
About this study
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- olfactory device
- Keywords
- olfactory device, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory deviceDevice
A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR).
| Study group | Role | What they receive |
|---|---|---|
| Outpatients (Drive Thru) | Patients receiving testing through a drive thru location. Receives: Device: olfactory device | |
| High Risk Asymptomatics | Asymptomatic patients (residents) in a high risk location. Receives: Device: olfactory device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
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.
Measured: 48 hours
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 Jun 2020
- Primary completion15 Oct 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R Peter Manes, MD, FACS, Principal investigator, Associate Professor of Surgery (Otolaryngology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431908
- Sponsor's protocol ID
- 2000028259
- Status last verified
- May 2021
- First submitted
- 12 Jun 2020
- Last updated
- 2 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35151176
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Rapid Quantitative Test for Loss of Smell in COVID-19 Subjects
- ClinicalTrials.gov ID
- NCT04431908
- Acronym / sponsor ID
- 2000028259
- Conditions
- COVID-19
- Keywords
- olfactory device, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,320 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Posted 2 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatients (Drive Thru) | – | Device: olfactory devicePatients receiving testing through a drive thru location. |
| High Risk Asymptomatics | – | Device: olfactory deviceAsymptomatic patients (residents) in a high risk location. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The population will be either individuals receiving drive-thru COVID-19 testing or residents of a nursing facility receiving tests.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olfactory deviceA quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR). | Device | High Risk Asymptomatics, Outpatients (Drive Thru) |
Primary outcome
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.
2 secondary outcomes
Repeatability
Time frame: 48 hours
Asymptomatic Sensitivity, Specificity and Accuracy
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35151176Patel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R Peter Manes, MD, FACS principal investigator
Associate Professor of Surgery (Otolaryngology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, Specificity and Accuracy (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04431908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.