COVID-19
Conditions
Keywords
olfactory device, COVID-19
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.
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.
Interventions
DEVICEolfactory device
A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR).
Sponsors
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity, Specificity and Accuracy | 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
| Measure | Time frame | Description |
|---|---|---|
| Repeatability | 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. |
| Asymptomatic Sensitivity, Specificity and Accuracy | 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. |
Countries
United States
Participant flow
Recruitment details
We did end up testing more individuals than expected due to increased ability
Participants by arm
| Arm | Count |
|---|---|
| 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). | 1,042 |
| High Risk Asymptomatics 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). | 278 |
| Total | 1,320 |
Baseline characteristics
| Characteristic | Outpatients (Drive Thru) | Total | High Risk Asymptomatics |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 164 Participants | 191 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 878 Participants | 1129 Participants | 251 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | — | 0 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | — | 0 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | — | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | — | 0 Participants | — |
| Race (NIH/OMB) Asian | — | 0 Participants | — |
| Race (NIH/OMB) Black or African American | — | 0 Participants | — |
| Race (NIH/OMB) More than one race | — | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | — | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | — | 0 Participants | — |
| Race (NIH/OMB) White | — | 0 Participants | — |
| Region of Enrollment United States | 1042 participants | 1320 participants | 278 participants |
| Sex: Female, Male Female | 615 Participants | 815 Participants | 200 Participants |
| Sex: Female, Male Male | 427 Participants | 505 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,042 | 0 / 278 |
| other Total, other adverse events | 0 / 1,042 | 0 / 278 |
| serious Total, serious adverse events | 0 / 1,042 | 0 / 278 |
Outcome results
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: * 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.
Time frame: 24 hours
Population: Only participants in the drive thru were analyzed for this outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Outpatients (Drive Thru) | Sensitivity, Specificity and Accuracy | True Negative | 889 Participants |
| Outpatients (Drive Thru) | Sensitivity, Specificity and Accuracy | False Positive | 106 Participants |
| Outpatients (Drive Thru) | Sensitivity, Specificity and Accuracy | False Negative | 27 Participants |
| Outpatients (Drive Thru) | Sensitivity, Specificity and Accuracy | True Positive | 20 Participants |
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) * 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.
Time frame: 24 hours
Population: Only asymptomatic patients were analyzed for this outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Outpatients (Drive Thru) | Asymptomatic Sensitivity, Specificity and Accuracy | True Negative | 244 Participants |
| Outpatients (Drive Thru) | Asymptomatic Sensitivity, Specificity and Accuracy | False Positive | 31 Participants |
| Outpatients (Drive Thru) | Asymptomatic Sensitivity, Specificity and Accuracy | False Negative | 27 Participants |
| Outpatients (Drive Thru) | Asymptomatic Sensitivity, Specificity and Accuracy | True Positive | 1 Participants |
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.
Time frame: 48 hours
Population: It was not feasible to get return visits as intended in the proposed protocol and therefore these data were not collected.