Status:

COMPLETED

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

Lead Sponsor:

Yale University

Conditions:

COVID-19

Eligibility:

All Genders

18+ years

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 l...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

June 15 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 18 2020

Estimated Enrollment :

1320 Patients enrolled

Trial Details

Trial ID

NCT04431908

Start Date

June 15 2020

End Date

November 18 2020

Last Update

June 2 2021

Active Locations (1)

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Yale New Haven Hospital

New Haven, Connecticut, United States, 06519