Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-27 @ 5:06 AM
Study NCT ID:
NCT05040659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-31
First Post:
2021-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086582', 'term': 'Anosmia'}, {'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000857', 'term': 'Olfaction Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '12 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of Aromha Longitudinal Smell Test results with upper respiratory illness', 'timeFrame': '12 weeks', 'description': 'To compare results of the Aromha Longitudinal smell test with test results of upper respiratory illnesses.'}, {'measure': 'Comparison of Aromha Longitudinal Smell Test results with vaccination status', 'timeFrame': '12 weeks', 'description': 'To compare results of the Aromha Longitudinal smell test with self-reported vaccination status.'}], 'primaryOutcomes': [{'measure': 'Aromha Longitudinal Smell Test', 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'Aromha Longitudinal Smell Test', 'timeFrame': '12 weeks', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Brief Smell Identification Test (BSIT)', 'timeFrame': '12 weeks', 'description': 'The BSIT is a battery of 12 odors with a score range from 0-12. Higher scores indicate a better sense of smell. We will evaluate previously diagnosed anosmic patients and healthy asymptomatic controls.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anosmia', 'Asymptomatic COVID-19', 'COVID-19 Respiratory Infection', 'Influenza', 'Healthy', 'PASC Post Acute Sequelae of COVID 19']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Diagnosis of Anosmia\n2. Healthy controls\n3. Asymptomatic patients\n4. Participants with COVID-19-related smell loss\n5. PASC with persistent smell loss', 'healthyVolunteers': True, 'eligibilityCriteria': 'For anosmic patients/healthy controls:\n\nInclusion criteria\n\n1. Known anosmia (for anosmic patients only)\n2. Age greater than or equal to 18\n3. Access to phone, tablet or computer connected to the internet.\n\nExclusion criteria\n\n1\\. Known odor-evoked adverse effects, e.g. asthma.\n\nFor asymptomatic participants:\n\nInclusion criteria\n\n1. No symptoms of COVID infection at the time of enrollment.\n2. Age greater than or equal to 18\n3. Access to phone, tablet or computer connected to the internet.\n\nExclusion criteria\n\n1\\. Known odor-evoked adverse effects, e.g. asthma.\n\nFor participants with COVID-19-related smell loss:\n\nInclusion criteria\n\n1. Past infection of SARS-CoV-2 virus as validated by a previous PCR or antigen test\n2. Age greater than or equal to 18\n3. Access to phone, tablet or computer connected to the internet.\n\nExclusion criteria\n\n1\\. Known odor-evoked adverse effects, e.g. asthma.'}, 'identificationModule': {'nctId': 'NCT05040659', 'briefTitle': 'Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2', 'orgStudyIdInfo': {'id': '2021P001988'}, 'secondaryIdInfos': [{'id': 'U01DC019579', 'link': 'https://reporter.nih.gov/quickSearch/U01DC019579', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '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.", 'interventionNames': ['Device: AROMHA Longitudinal Smell Test']}, {'label': '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.", 'interventionNames': ['Device: AROMHA Longitudinal Smell Test']}, {'label': '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.", 'interventionNames': ['Device: AROMHA Longitudinal Smell Test']}, {'label': 'PASC', 'description': "Known history of CSD (chemosensory dysfunction) associated with a COVID-19 infection characterized in Dr.Lora Bankova's clinical study (MGB) .", 'interventionNames': ['Device: AROMHA Longitudinal Smell Test']}], 'interventions': [{'name': 'AROMHA Longitudinal Smell Test', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Anosmic patients', 'Asymptomatic participants / Healthy participants', 'PASC', 'Participants with a confirmed COVID-19 infection or related smell loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Mark W Albers, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'The data will be available indefinitely and will be updated every 3 months. Our first data set will be shared in December of 2021.', 'ipdSharing': 'YES', 'description': 'We will be sharing the results from the smell test, the answers in the demographic questionnaire, and the PCR results in a de-identified manner.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Frank Wilkens and Family Endowed Scholar/ Asst. Prof. Neurology', 'investigatorFullName': 'Mark W Albers', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}