Clinical trial NCT05040659: Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2
Official title: Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anosmia
Asymptomatic COVID-19
COVID-19 Respiratory Infection
Influenza
Healthy
PASC Post Acute Sequelae of COVID 19
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-09-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Aromha Longitudinal Smell Test
timeFrame: 12 weeks
measure: Aromha Longitudinal Smell Test
timeFrame: 12 weeks
Secondary outcomes:
measure: Brief Smell Identification Test (BSIT)
timeFrame: 12 weeks
Other outcomes:
measure: Comparison of Aromha Longitudinal Smell Test results with upper respiratory illness
timeFrame: 12 weeks
measure: Comparison of Aromha Longitudinal Smell Test results with vaccination status
timeFrame: 12 weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Mark W Albers, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: