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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anosmia, Asymptomatic COVID-19, COVID-19 Respiratory Infection, Influenza, Healthy

Intervention / Treatment
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* Device: AROMHA Longitudinal Smell Test


Participation Criteria
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Eligibility Criteria
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For anosmic patients/healthy controls: Inclusion criteria Known anosmia (for anosmic patients only) Age greater than or equal to 18 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 No symptoms of COVID infection at the time of enrollment. Age greater than or equal to 18 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 Past infection of SARS-CoV-2 virus as validated by a previous PCR or antigen test Age greater than or equal to 18 Access to phone, tablet or computer connected to the internet. Exclusion criteria 1. Known odor-evoked adverse effects, e.g. asthma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anosmic patients<br>Anosmic patients will be recruited from Dr. Albers Smell Clinic at MGH and through past participation in research with known anosmia and permission to recontact. All consent and testing will occur on a phone/tablet app in the participant's home. | Device: AROMHA Longitudinal Smell Test<br>* 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.<br>|
| Asymptomatic participants / Healthy participants<br>Asymptomatic participants recruited in a hospital setting (eg. healthcare workers and household members of symptomatic patients who are potentially COVID positive). No symptoms of COVID infection at the time of enrollment. Potential or definite exposure to SARS-CoV-2 virus without symptoms of upper respiratory infection (smell loss, taste loss, fever, myalgia, cough, nasal congestion, runny nose, shortness of breath). All consent and testing will occur on a phone/tablet app in the participant's home. | Device: AROMHA Longitudinal Smell Test<br>* 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.<br>|
| Participants with a confirmed COVID-19 infection or related smell loss<br>Individuals who tested positive for SARS-CoV2 by an objective PCR or antigen test will be recruited to evaluate smell function weekly over 3 months. All consent and testing will occur on a phone/tablet app in the participant's home. | Device: AROMHA Longitudinal Smell Test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |