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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02129
Contact:
Mark W Albers, MD PhD
617-724-7401
albers.mark@mgh.harvard.edu

More Details

NCT ID
NCT05040659
Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Daniela Clinical Research Coordinator, BS
5082160913
Olfactionstudy18@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.