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

NCT ID: NCT05040659

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2025-05-31

Brief 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.

Conditions

Anosmia; Asymptomatic COVID-19; COVID-19 Respiratory Infection; Influenza; Healthy; PASC Post Acute Sequelae of COVID 19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

AROMHA Longitudinal Smell Test

Intervention Type: DEVICE

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.

AROMHA Longitudinal Smell Test

Intervention Type: DEVICE

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.

AROMHA Longitudinal Smell Test

Intervention Type: DEVICE

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) .

AROMHA Longitudinal Smell Test

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mark W Albers

Frank Wilkens and Family Endowed Scholar/ Asst. Prof. Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark W Albers, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

U01DC019579

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021P001988

Identifier Type: -

Identifier Source: org_study_id