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

NCT05040659 | Active Not Recruiting

• 2 other identifiers: 2021P001988U01DC019579
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (1)

• Brief Smell Identification Test (BSIT)

  12 weeks

Other Outcomes (2)

• Comparison of Aromha Longitudinal Smell Test results with upper respiratory illness

  12 weeks

• Comparison of Aromha Longitudinal Smell Test results with vaccination status

  12 weeks

Study Arms (4)

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

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

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

PASC

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

Device: AROMHA Longitudinal Smell Test

Interventions

AROMHA Longitudinal Smell Test 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.

Anosmic patients; Asymptomatic participants / Healthy participants; PASC; Participants with a confirmed COVID-19 infection or related smell loss

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• \. Known odor-evoked adverse effects, e.g. asthma.
• For asymptomatic participants:
• 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.
• \. Known odor-evoked adverse effects, e.g. asthma.
• For participants with COVID-19-related smell loss:
• 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.
• \. Known odor-evoked adverse effects, e.g. asthma.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Anosmia; Influenza, Human; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; COVID-19; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Mark W Albers, MD PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Frank Wilkens and Family Endowed Scholar/ Asst. Prof. Neurology

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: September 10, 2021
• Study Start: November 14, 2022
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The data will be available indefinitely and will be updated every 3 months. Our first data set will be shared in December of 2021.
• Access Criteria: This study is part of the NIH RADx program, which requires sharing of de-identified participant data with a central data coordination center (RADx Data Hub). We will be sharing this information through the NIH dbGAP protocol.

Locations

US (1)