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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatients (Drive Thru) | Patients receiving testing through a drive thru location. |
| |
| High Risk Asymptomatics | Asymptomatic patients (residents) in a high risk location. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olfactory device | Device | A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Asymptomatic Sensitivity, Specificity and Accuracy |
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Inclusion Criteria:
Exclusion Criteria:
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The population will be either individuals receiving drive-thru COVID-19 testing or residents of a nursing facility receiving tests.
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| Name | Affiliation | Role |
|---|---|---|
| R Peter Manes, MD, FACS | Associate Professor of Surgery (Otolaryngology) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35151176 | Derived | 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. |
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We did end up testing more individuals than expected due to increased ability
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| ID | Title | Description |
|---|---|---|
| FG000 | Outpatients (Drive Thru) | Patients receiving testing through a drive thru location. olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR). |
| FG001 | High Risk Asymptomatics | Asymptomatic patients (health care workers) in a high risk location. olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Outpatients (Drive Thru) | Patients receiving testing through a drive thru location. olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR). |
| BG001 | High Risk Asymptomatics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
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. | Only participants in the drive thru were analyzed for this outcome. | Posted | Count of Participants | Participants | 24 hours |
|
An average of 30 minutes after administration of the smell test
Serious and Other Adverse Event definitions do not differ from those of ClinicalTrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Outpatients (Drive Thru) | Patients receiving testing through a drive thru location. olfactory device: 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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It is possible that the PCR COVID test results were incorrect, as these tests are not 100% accurate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. R. Peter Manes | Yale School of Medicine | (203) 785-5430 | rpeter.manes@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2020 | Mar 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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 |
Asymptomatic patients (residents) in a high risk location. olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Race and Ethnicity data were not collected for the purposes of this study. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race and Ethnicity data were not collected for the purposes of this study. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | Outpatients (Drive Thru) | Patients receiving testing through a drive thru location. olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR). |
|
|
|
| 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. | It was not feasible to get return visits as intended in the proposed protocol and therefore these data were not collected. | Posted | 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)
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. | Only asymptomatic patients were analyzed for this outcome. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
|
| 0 |
| 1,042 |
| 0 |
| 1,042 |
| 0 |
| 1,042 |
| EG001 | High Risk Asymptomatics | Asymptomatic patients (health care workers) in a high risk location. olfactory device: A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR). | 0 | 278 | 0 | 278 | 0 | 278 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| True Positive |
|
|
| Sensitivity |
| 33.33 |
| 2-Sided |
| Other |
Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test. |
| Accuracy | 88.13 | 2-Sided | Other | Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test. |