dbGaP Study Accession: phs002964

NIH Institute/Center: NIDCD

RADx Data Program: RADx-rad

DOI: 10.60773/xb7r-qw92

Release Date: 08/30/2024

Study Description: Self-report of sudden loss of smell or taste substantially increases the odds of being infected with SARS-CoV-2. However, self-report of smell function is an unreliable predictor of smell loss. The study created a self-administered easy to use "at home" 5-minute objective smell test to uncover alterations in smell function unbeknownst to many individuals and confer increased risk of infection by SARS- CoV-2. The new smell test consists of a physical smell card containing peel and sniff odor labels and a web- based application. Each participant accessed the web-based app on their own smartphone, tablet, or computer. The study developed a native app to conduct longitudinal COVID Smell Test (Aim 1), collect data on asymptomatic health care workers, symptomatic patients, and undergraduates (Aim 2) and develop algorithms for the longitudinal smell test for personalized thresholds, differentiate smell loss from COVID relative to influenza (Aim 3). The Longitudinal COVID Smell Test was accessible, affordable, and readily scalable. Effective screening with the COVID smell test better informed students and employees if they should not report to school or work and seek an evaluation by a healthcare professional.

Updated Date: 01/18/2024

Principal Investigator: Albers, Mark

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Diagnostic Testing; Digital Health Applications; Influenza

Data Collection Method: Chemosensory Testing Device

Keywords: Anosmia; Ansomic Patients; Healthcare Workers; Odor Discrimination; Odor Identification; Odor Intensity; Olfaction; Olfactory Function; Olfactory Testing; Smell Function; Smell Test; Symptomatic Population

Study Design: Longitudinal Cohort

Multi-Center Study: Yes

Study Sites: University of Maryland

Data Types: Clinical; Electronic Medical Records; Questionnaire or Survey

Study Start Date: 12/21/2020

Study End Date: 05/31/2023

Species: Human

Estimated Cohort Size: 6000

Study Population Focus: Adults; Essential Workers; Older Adults or Elderly

Study Website URL: https://rally.massgeneralbrigham.org/study/at_home_covidsmell_test_

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05040659

Acknowledgement Statement: This study was supported through funding, 4U01DC019579-03, for the National Institute on Deafness and Other Communication Disorders (NIDCD) as part of the RADx-rad program. This work was supported by Principal Investigator Dr. Mark Albers. A special acknowledgment to our Collaborating site, University of Maryland, our study team, research staff, and the study participants that made this project possible. Approved users should acknowledge the provision of data access by dbGaP for accession phs002964.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: RFA-OD-20-022

NIH Grant or Contract Number(s): 4U01DC019579-03

Consent/Data Use Limitations: General Research Use