Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-01 @ 10:49 PM
Study NCT ID:
NCT05156593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
'Long COVID-19' in Suffolk and North Essex: Defining the Disease and Optimising Outcomes
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-06', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2021-12-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomology', 'timeFrame': '36 months', 'description': 'Wide range of symptoms associated with Long COVID'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'To accurately describe the rehabilitation needs of individuals with post-COVID-19 syndrome up to 36 months after infection, allowing better diagnosis, triage and resource management. A major focus will be the impact on everyday life to return to normal activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with diagnosed Long COVID', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria Individuals 18 years old and over (no upper age limit) Female and male Diagnosed with COVID-19 via PCR testing Or, Experienced symptoms of COVID-19 (new continuous cough, a high temperature, loss of taste and smell) And Clinically diagnosed with Post-COVID-19 Syndrome by their GP Participants who live within Suffolk and North East Essex\n\nExclusion criteria Individuals unable to consent for themselves Individuals without sufficient proficiency in English language to take part in telephone or video call, where the research team have been unable to make adjustments to enable their participation Individuals under 18 years old'}, 'identificationModule': {'nctId': 'NCT05156593', 'briefTitle': "'Long COVID-19' in Suffolk and North Essex: Defining the Disease and Optimising Outcomes", 'organization': {'class': 'OTHER', 'fullName': 'East Suffolk and North Essex NHS Foundation Trust'}, 'officialTitle': "'Long COVID' in Suffolk and North Essex: Defining the Disease and Optimising Outcomes", 'orgStudyIdInfo': {'id': '20/187'}}, 'contactsLocationsModule': {'locations': [{'zip': 'IP4 5PD', 'city': 'Ipswich', 'country': 'United Kingdom', 'facility': 'East Suffolk and North Essex NHS Foundation Trust', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}], 'overallOfficials': [{'name': 'Kate Harrall', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Suffolk and North Essex NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Suffolk and North Essex NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}