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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Influenza; Anosmia; COVID-19 Respiratory Infection; Asymptomatic COVID-19; PASC Post Acute Sequelae of COVID 19
• Intervention / Treatment: Device: AROMHA Longitudinal Smell Test

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

1. Diagnosis of Anosmia
2. Healthy controls
3. Asymptomatic patients
4. Participants with COVID-19-related smell loss
5. PASC with persistent smell loss

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anosmic patients; 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; 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.
Asymptomatic participants / Healthy participants; 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; 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.
Participants with a confirmed COVID-19 infection or related smell loss; 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; 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.
PASC; Known history of CSD (chemosensory dysfunction) associated with a COVID-19 infection characterized in Dr.Lora Bankova's clinical study (MGB) .	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Mark W Albers, MD PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): December 30, 2024
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Sensation Disorders; Olfaction Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anosmia; Post-Acute COVID-19 Syndrome; Influenza, Human
• Other Study ID Numbers: 2021P001988; U01DC019579 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will be sharing the results from the smell test, the answers in the demographic questionnaire, and the PCR results in a de-identified manner.
• IPD Sharing Time Frame: The data will be available indefinitely and will be updated every 3 months. Our first data set will be shared in December of 2021.
• IPD Sharing Access Criteria: This study is part of the NIH RADx program, which requires sharing of de-identified participant data with a central data coordination center (RADx Data Hub). We will be sharing this information through the NIH dbGAP protocol.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No