N/A N=1,320

Validation of a Rapid Quantitative Test for Loss of Smell in COVID-19 Subjects

COVID-19

Bottom Line

View on ClinicalTrials.gov: NCT04431908 ↗

Enrolled (actual)

1,320

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Sensitivity, Specificity and Accuracy — 889; 106; 27; 20 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: olfactory device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Sensitivity, Specificity and Accuracy	889; 106; 27; 20	—
SECONDARY Repeatability	—	—
SECONDARY Asymptomatic Sensitivity, Specificity and Accuracy	244; 31; 27; 1	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04431908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.