Trial Outcomes & Findings for Validation of a Rapid Quantitative Test for Loss of Smell in COVID-19 Subjects (NCT NCT04431908)

NCT ID: NCT04431908

Last Updated: 2021-06-02

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 1320 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2021-06-02

Participant Flow

We did end up testing more individuals than expected due to increased ability

Participant milestones

Measure	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).	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).
Overall Study STARTED	1042	278
Overall Study COMPLETED	1042	278
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity data were not collected for the purposes of this study.

Baseline characteristics by cohort

Measure	Outpatients (Drive Thru) n=1042 Participants 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).	High Risk Asymptomatics n=278 Participants 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).	Total n=1320 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1042 Participants	0 Participants n=278 Participants	0 Participants n=1320 Participants
Age, Categorical Between 18 and 65 years	878 Participants n=1042 Participants	251 Participants n=278 Participants	1129 Participants n=1320 Participants
Age, Categorical >=65 years	164 Participants n=1042 Participants	27 Participants n=278 Participants	191 Participants n=1320 Participants
Sex: Female, Male Female	615 Participants n=1042 Participants	200 Participants n=278 Participants	815 Participants n=1320 Participants
Sex: Female, Male Male	427 Participants n=1042 Participants	78 Participants n=278 Participants	505 Participants n=1320 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	—	0 Participants Race and Ethnicity data were not collected for the purposes of this study.
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	—	0 Participants Race and Ethnicity data were not collected for the purposes of this study.
Ethnicity (NIH/OMB) Unknown or Not Reported	—	—	0 Participants Race and Ethnicity data were not collected for the purposes of this study.
Race (NIH/OMB) American Indian or Alaska Native	—	—	0 Participants Race and Ethnicity data were not collected for the purposes of this study.
Race (NIH/OMB) Asian	—	—	0 Participants Race and Ethnicity data were not collected for the purposes of this study.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	0 Participants Race and Ethnicity data were not collected for the purposes of this study.
Race (NIH/OMB) Black or African American	—	—	0 Participants Race and Ethnicity data were not collected for the purposes of this study.
Race (NIH/OMB) White	—	—	0 Participants Race and Ethnicity data were not collected for the purposes of this study.
Race (NIH/OMB) More than one race	—	—	0 Participants Race and Ethnicity data were not collected for the purposes of this study.
Race (NIH/OMB) Unknown or Not Reported	—	—	0 Participants Race and Ethnicity data were not collected for the purposes of this study.
Region of Enrollment United States	1042 participants n=1042 Participants	278 participants n=278 Participants	1320 participants n=1320 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Only participants in the drive thru were analyzed for this outcome.

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.

Outcome measures

Measure	Outpatients (Drive Thru) n=1042 Participants 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).	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).
Sensitivity, Specificity and Accuracy True Negative	889 Participants	—
Sensitivity, Specificity and Accuracy False Positive	106 Participants	—
Sensitivity, Specificity and Accuracy False Negative	27 Participants	—
Sensitivity, Specificity and Accuracy True Positive	20 Participants	—

SECONDARY outcome

Timeframe: 48 hours

Population: It was not feasible to get return visits as intended in the proposed protocol and therefore these data were not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Population: Only asymptomatic patients were analyzed for this outcome.

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.

Outcome measures

Measure	Outpatients (Drive Thru) n=278 Participants 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).	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).
Asymptomatic Sensitivity, Specificity and Accuracy True Negative	244 Participants	—
Asymptomatic Sensitivity, Specificity and Accuracy False Positive	31 Participants	—
Asymptomatic Sensitivity, Specificity and Accuracy False Negative	27 Participants	—
Asymptomatic Sensitivity, Specificity and Accuracy True Positive	1 Participants	—

Adverse Events

Outpatients (Drive Thru)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Risk Asymptomatics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. R. Peter Manes

Yale School of Medicine

Phone: (203) 785-5430

Email: rpeter.manes@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place