AnosmiaNCT05040659
Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2
An observational study of Anosmia and Asymptomatic COVID-19, run by Massachusetts General Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Anosmia, Asymptomatic COVID-19, COVID-19 Respiratory Infection
- What is being tested?
- AROMHA Longitudinal Smell Test
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2022to 31 Dec 2027
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Known anosmia (for anosmic patients only)
- Age greater than or equal to 18
- Access to phone, tablet or computer connected to the internet.
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 1. Known odor-evoked adverse effects, e.g. asthma.
- For asymptomatic participants:
- 1. Known odor-evoked adverse effects, e.g. asthma.
- For participants with COVID-19-related smell loss:
- 1. Known odor-evoked adverse effects, e.g. asthma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02129
About this study
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.
- Conditions
- Anosmia, Asymptomatic COVID-19, COVID-19 Respiratory Infection, Influenza, Healthy, PASC Post Acute Sequelae of COVID 19
- Being tested
- AROMHA Longitudinal Smell Test
- Medical subject headings
- Anosmia, Influenza, Human, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AROMHA Longitudinal Smell TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AROMHA Longitudinal Smell Test | |
| 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. Receives: Device: AROMHA Longitudinal Smell Test | |
| 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. Receives: Device: AROMHA Longitudinal Smell Test | |
| PASC | Known history of CSD (chemosensory dysfunction) associated with a COVID-19 infection characterized in Dr.Lora Bankova's clinical study (MGB) . Receives: Device: AROMHA Longitudinal Smell Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start14 Nov 2022
- Primary completion30 Dec 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Mark W Albers, Massachusetts General Hospital
- Investigators
- Mark W Albers, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040659
- Sponsor's protocol ID
- 2021P001988
- Other IDs
- U01DC019579
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2
- ClinicalTrials.gov ID
- NCT05040659
- Acronym / sponsor ID
- 2021P001988
- Conditions
- Anosmia, Asymptomatic COVID-19, COVID-19 Respiratory Infection, Influenza, Healthy, PASC Post Acute Sequelae of COVID 19
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anosmic patients | – | Device: AROMHA Longitudinal Smell TestAnosmic 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. |
| Asymptomatic participants / Healthy participants | – | Device: AROMHA Longitudinal Smell TestAsymptomatic 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. |
| Participants with a confirmed COVID-19 infection or related smell loss | – | Device: AROMHA Longitudinal Smell TestIndividuals 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. |
| PASC | – | Device: AROMHA Longitudinal Smell TestKnown history of CSD (chemosensory dysfunction) associated with a COVID-19 infection characterized in Dr.Lora Bankova's clinical study (MGB) . |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- Known anosmia (for anosmic patients only)
- Age greater than or equal to 18
- Access to phone, tablet or computer connected to the internet.
- No symptoms of COVID infection at the time of enrollment.
- Age greater than or equal to 18
Key exclusion criteria (5 listed)
- 1. Known odor-evoked adverse effects, e.g. asthma.
- 1. Known odor-evoked adverse effects, e.g. asthma.
- 1. Known odor-evoked adverse effects, e.g. asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AROMHA Longitudinal Smell TestThe 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. | Device | Anosmic patients, Asymptomatic participants / Healthy participants, PASC, Participants with a confirmed COVID-19 infection or related smell loss |
Primary outcome
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.
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.
1 secondary outcome
Brief Smell Identification Test (BSIT)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark W Albers, MD PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anosmia and Asymptomatic COVID-19, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aromha Longitudinal Smell Test (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.