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

Mass General Brigham

Status

Active, not recruiting

Conditions

Healthy

COVID-19 Respiratory Infection

Anosmia

Influenza

PASC Post Acute Sequelae of COVID 19

Asymptomatic COVID-19

Treatments

Device: AROMHA Longitudinal Smell Test

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05040659

U01DC019579 (U.S. NIH Grant/Contract)

2021P001988

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

For anosmic patients/healthy controls:

Inclusion criteria

Known anosmia (for anosmic patients only)
Age greater than or equal to 18
Access to phone, tablet or computer connected to the internet.

Exclusion criteria

Known odor-evoked adverse effects, e.g. asthma.

For asymptomatic participants:

Inclusion criteria

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.

Exclusion criteria

Known odor-evoked adverse effects, e.g. asthma.

For participants with COVID-19-related smell loss:

Inclusion criteria

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.

Exclusion criteria

Known odor-evoked adverse effects, e.g. asthma.

Trial design

1,000 participants in 4 patient groups

Anosmic patients

Description:

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.

Treatment:

Device: AROMHA Longitudinal Smell Test

Asymptomatic participants / Healthy participants

Description:

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.

Treatment:

Device: AROMHA Longitudinal Smell Test

Participants with a confirmed COVID-19 infection or related smell loss

Description:

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.

Treatment:

Device: AROMHA Longitudinal Smell Test

PASC

Description:

Known history of CSD (chemosensory dysfunction) associated with a COVID-19 infection characterized in Dr.Lora Bankova's clinical study (MGB) .

Treatment:

Device: AROMHA Longitudinal Smell Test