Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-02 @ 1:55 PM
Study NCT ID:
NCT05508295
Status:
UNKNOWN
Last Update Posted:
2023-06-26
First Post:
2022-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long COVID-19 and MAB Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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': 'D018352', 'term': 'Coronavirus Infections'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-08-17', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adopt the NIH PROMIS system (The Assessment Center Instrument Library, which includes all Fixed Length Short Form and Computer Adaptive Test/Item Bank instruments from PROMIS) to construct a modified comprehensive PRO instrument.', 'timeFrame': '18-month study length, with a pilot reliability study.', 'description': 'Using a modified NIH PRO measurement system. This system will involve different domains and instruments. Patients will answer PRO questions at the time of recruitment (baseline), then followed up 3 months and 6 months after the first survey (follow-up).\n\nThe modified comprehensive PRO instrument will specifically ask patients to report symptoms based on their health status within a fixed time window, and at the time when the survey questions are given.'}], 'secondaryOutcomes': [{'measure': 'Selected comorbidities, all-cause hospitalization and ER visits.', 'timeFrame': '3 months and 6 months follow-up.', 'description': "Extracted from patients' electronic health records."}, {'measure': "Patients' COVID vaccination and mAb therapy history will be verified based on self report and EHR.", 'timeFrame': '18-month study length'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study will be observational only. It will provide real-world evidence generated from a representative and large-scale COVID patient base. The adoption, pilot testing and use of NIH PROs among viral tested patients with research purpose on long COVID will be unique and innovative. With the existing and proven scientific rigor, NIH PRO system will be adopted, then modified and tailored to form the long hauler specific, comprehensive instrument, helping generalize future knowledge regarding COVID-infected patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A small representative sample of up to 50 patients (25 hospitalized and alive at the time of the extraction) will be randomly selected and invited to test for the PRO instrument', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been tested for COVID at one of the MultiCare facilities,\n* AND 18 years old or older at the viral test,\n* AND have no problem understanding English or Spanish.\n\nExclusion Criteria:\n\n* Pediatric patients younger than 18 years old at the time of testing,\n* OR patients who are pregnant,\n* OR patients who plan to get pregnant in 3 months,\n* OR patients who are hospitalized at the time of recruitment,\n* OR patients who have cognitive impairment(s) at the recruitment.'}, 'identificationModule': {'nctId': 'NCT05508295', 'briefTitle': 'Long COVID-19 and MAB Study', 'organization': {'class': 'OTHER', 'fullName': 'MultiCare Health System Research Institute'}, 'officialTitle': 'Setting up a Community Based Patient Cohort to Understand Long COVID: Monoclonal Antibody and Post-Infection COVID Vaccine Administration as the FOCI', 'orgStudyIdInfo': {'id': '02/01/2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID positive case with mAb treatment'}, {'label': 'COVID positive case having not received mAb treatment'}, {'label': 'COVID negative cases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jin Mou, MD, MSc, MPH, Ph.D', 'role': 'CONTACT', 'email': 'Jin.Mou@multicare.org', 'phone': '253.403.7250'}, {'name': 'Jin Mou, MD, MSc, MPH, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Robin Underwood, RN, BSN, VA-BC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Garrett, DNP, ARNP, FNP-BC, MHA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'MultiCare Health System', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'centralContacts': [{'name': 'Hollis Zeng', 'role': 'CONTACT', 'email': 'hzeng38@emory.edu', 'phone': '2534037250'}, {'name': 'Jin Mou', 'role': 'CONTACT', 'email': 'jin.mou@multicare.org', 'phone': '2534037250'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MultiCare Health System Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}