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

March 4, 2026 updated by: Mark W Albers, Massachusetts General Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aromha Longitudinal Smell Test
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief Smell Identification Test (BSIT)
Time Frame: 12 weeks
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of Aromha Longitudinal Smell Test results with upper respiratory illness
Time Frame: 12 weeks
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
Time Frame: 12 weeks
To compare results of the Aromha Longitudinal smell test with self-reported vaccination status.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark W Albers, MD PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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