Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2

Healthy Clinical Trial

Official title:

Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05040659
• Other study ID #: 2021P001988
• Secondary ID: U01DC019579
• Status: Recruiting
• Start date: November 14, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Daniela Clinical Research Coordinator, BS
• Phone: 5082160913
• Email: Olfactionstudy18[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to learn more about how to better track smell recovery in people who have been infected with the SARS-CoV-2 virus (which causes COVID-19). Many people who have been infected by this virus develop changes in their sense of smell (olfaction). We are interested in measuring smell function objectively via smell cards that test odor intensity, identification, and discrimination. Objective and precise olfactory testing that can be performed in the convenience of one's home will help identify people with smell loss after infection by SARS-CoV-2. We will use results from this test to better understand the relationship between SARS-CoV-2 infection and recovery of olfactory function and to learn whether the AROMHA longitudinal smell test is a reliable olfactory function tracking tool to quantify smell loss in the context of COVID infection. These results may inform the design of therapeutic clinical trials to accelerate the recovery of smell function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 1, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

For anosmic patients/healthy controls:

Inclusion criteria

1. Known anosmia (for anosmic patients only)

2. Age greater than or equal to 18

3. Access to phone, tablet or computer connected to the internet.

Exclusion criteria

1. Known odor-evoked adverse effects, e.g. asthma.

For asymptomatic participants:

Inclusion criteria

1. No symptoms of COVID infection at the time of enrollment.

2. Age greater than or equal to 18

3. Access to phone, tablet or computer connected to the internet.

Exclusion criteria

1. Known odor-evoked adverse effects, e.g. asthma.

For participants with COVID-19-related smell loss:

Inclusion criteria

1. Past infection of SARS-CoV-2 virus as validated by a previous PCR or antigen test

2. Age greater than or equal to 18

3. Access to phone, tablet or computer connected to the internet.

Exclusion criteria

1. Known odor-evoked adverse effects, e.g. asthma.

Related Conditions & MeSH terms

• Anosmia
• Communicable Diseases
• COVID-19
• Healthy
• Infections
• Influenza
• Respiratory Tract Infections

Intervention

Device:
• AROMHA Longitudinal Smell Test
The AROMHA Longitudinal Smell Test is a self-administered, at-home smell test intended for use as a screening test by asymptomatic individuals to help prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19, through a serial testing approach. The device consists of six versions of a smell card, each containing three unique odors.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of Aromha Longitudinal Smell Test results with upper respiratory illness	To compare results of the Aromha Longitudinal smell test with test results of upper respiratory illnesses.	12 weeks
Other	Comparison of Aromha Longitudinal Smell Test results with vaccination status	To compare results of the Aromha Longitudinal smell test with self-reported vaccination status.	12 weeks
Primary	Aromha Longitudinal Smell Test	The Aromha Smell Test is a battery of 18 odors across 6 smell cards. The subject smells each of the 3 scents per card to determine smell intensity, identification, and discrimination. Increased number of correct responses indicates better sense of smell. We will evaluate previously diagnosed anosmic patients.	12 weeks
Primary	Aromha Longitudinal Smell Test	The Aromha Smell Test is a battery of 18 odors across 6 smell cards. The subject smells each of the 3 scents per card to determine smell intensity, identification, and discrimination. Increased number of correct responses indicates better sense of smell. The subject's scores on the longitudinal olfactory tests will be compared to the self-reported COVID test results (SARS-CoV-2 negative or positive) of asymptomatic and symptomatic individuals.	12 weeks
Secondary	Brief Smell Identification Test (BSIT)	The BSIT is a battery of 12 odors with a score range from 0-12. Higher scores indicate a better sense of smell. We will evaluate previously diagnosed anosmic patients and healthy asymptomatic controls.	12 weeks