Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 9:55 PM
Study NCT ID:
NCT04393961
Status:
UNKNOWN
Last Update Posted:
2020-05-19
First Post:
2020-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is a device feasibility trial. There is no blinding or masking.'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will include four arms. The experiences across all 4 arms will be exactly the same. Each arm has a slightly different experience with COVID-19.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-08-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-16', 'studyFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2020-05-16', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Does Participant Accurately Read Result', 'timeFrame': 'Day 0', 'description': 'Comparison of participant reported self-test result vs physician review of self-test results via participant reported photograph of the test'}, {'measure': 'Acceptability and Usability of Tests', 'timeFrame': 'Day 0', 'description': 'Mesure of participant self report on ease of test administration via a custom survey assessment'}], 'secondaryOutcomes': [{'measure': 'Social Distancing Behavior Change', 'timeFrame': 'Week 8', 'description': 'Change in Actual vs Anticipated social distancing behavior as measured by modified PROMIS Satisfaction with Social Questionnaire.'}, {'measure': 'COVID-19 Related Anxiety', 'timeFrame': 'Week 8', 'description': 'Change in economic, personal and other anxiety triggers as measured by a modified version of the Zung Self-Rating Anxiety Scale.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['antibody', 'testing', 'remote trial'], 'conditions': ['COVID19', 'COVID-19', 'Coronavirus']}, 'descriptionModule': {'briefSummary': 'Radish Health and ProofPilot in coordination with Sanesco are running this study to help establish whether the Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma Authorized for distribution under emergency use authorization - though not yet FDA reviewed) can be conducted effectively at home to detect COVID-19 antibodies among individuals who have tested positive, or suspect they have previous contracted from COVID-19 and recovered. The study also aims to examine how the results of those tests change social-distancing behaviors and general anxiety over 8 weeks post-test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reside and Currently in New York City\n* Does not have a blood clotting disease\n* Is not abnormally queasy about taking a blood sample\n* Not on any blood thinning medications\n* Able to consent\n* Willingness to take a blood sample\n* Confirmed of highly likely past infection with COVID-19 over 14 days ago and fully recovered'}, 'identificationModule': {'nctId': 'NCT04393961', 'briefTitle': 'At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'ProofPilot'}, 'officialTitle': 'At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study', 'orgStudyIdInfo': {'id': '2458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Past Positive COVID-19 confirmed', 'description': 'Invited participants who Radish Health has completed a positive COVID-19 test who have recovered from all symptoms for more than 14 days.', 'interventionNames': ['Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette']}, {'type': 'OTHER', 'label': 'Physician Diagnosed: Not Tested', 'description': 'Individuals who self report that a medical professional has told them they likely have COVID-19 (and have since recovered), but did not get a confirmatory test.', 'interventionNames': ['Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette']}, {'type': 'OTHER', 'label': 'Self-Diagnosed Not Tested', 'description': 'Participant suspects they contracted (and have since recovered) from COVID-19, but they do not have a medical diagnosis or confirmatory test.', 'interventionNames': ['Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette']}, {'type': 'OTHER', 'label': 'Likely Exposed, No Symptoms. Not Tested', 'description': "Participant suspects that they've been exposed to COVID-19, but have not shown symptoms and wonder if they have antibodies so they may return to some normalcy.", 'interventionNames': ['Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette']}], 'interventions': [{'name': 'Premier Biotech COVID-19 IgG/IgM Rapid test Cassette', 'type': 'DEVICE', 'description': "Current emergency situation, there are large numbers of COVID-19 Antibody tests being made available at a record pace.\n\nThe protocol is designed to be test agnostic. However, for this first volley, we have chosen the The COVID-19 IgG and IgM Rapid Test provided by Premier Biotech.\n\nWe chose the Precision Bio test for 4 reasons\n\n1. It is available as a single use test kit in one sealed unit.\n2. It's a rapid test, with results available in 10 minutes.\n3. It has clear and easy to read instructions already included\n4. It has one of the lowest false positive rates of known tests at the moment", 'armGroupLabels': ['Likely Exposed, No Symptoms. Not Tested', 'Past Positive COVID-19 confirmed', 'Physician Diagnosed: Not Tested', 'Self-Diagnosed Not Tested']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Amsden', 'role': 'CONTACT', 'email': 'crew@proofpilot.com'}], 'facility': 'ProofPilot Online App (https://p.proofpilot.com)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Viral Patel, MD', 'role': 'CONTACT', 'email': 'crew@proofpilot.com', 'phone': '(833)-4-RADISH'}, {'name': 'Matthew Amsden', 'role': 'CONTACT', 'email': 'crew@proofpilot.com'}]}, 'ipdSharingStatementModule': {'url': 'http://go.proofpilot.com', 'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'As soon reasonably sized data sets are available.', 'ipdSharing': 'YES', 'description': 'Given the enormous policy and health implications, we will be making results available as soon as there are sufficient data sets to analyze. We will also provide our study design for replication in other environments and via other tests.', 'accessCriteria': 'No personally identifiable information will be provided. Those who wish to access must have a ProofPilot account. All access must be approved by study investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProofPilot', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Radish Health', 'class': 'UNKNOWN'}, {'name': 'Sanesco', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}