Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 11:43 PM
Study NCT ID:
NCT06879535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-17
First Post:
2025-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Symptomatic Follow-up of Patients with Long COVID Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'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'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': 'From enrollment to three years later', 'description': 'MFIS scale'}, {'measure': 'Emotional disorders', 'timeFrame': 'From enrollment to three years later', 'description': 'HADS scale'}, {'measure': 'Sleep disorders', 'timeFrame': 'From enrollment to three years later', 'description': 'PSQI'}, {'measure': 'Cognitive impairments', 'timeFrame': 'From enrollment to three years later', 'description': 'MFE-30'}, {'measure': 'Dyspnea', 'timeFrame': 'From enrollment to three years later', 'description': 'mMRC'}, {'measure': 'Physical activity', 'timeFrame': 'From enrollment to three years later', 'description': 'GPAQ'}, {'measure': 'Quality of life (healthcare)', 'timeFrame': 'From enrollment to three years later', 'description': 'SF-36'}, {'measure': 'Pain (healthcare)', 'timeFrame': 'From enrollment to three years later', 'description': 'EGDC'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Long COVID', 'Long-term follow-up', 'Symptoms', 'Scales'], 'conditions': ['Long COVID']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the long-term evolution of long COVID.\n\nThe main question it aims to answer is:\n\nDoes the main symptoms of the patients diagnosed with long COVID aproximate to those of patients who have had COVID acute infection without devoloping long COVID? Participants will answer mailed survey questions about their main symptons.', 'detailedDescription': 'Scales, indexes and questionnaires were mailed to 40 patients with long COVID to evaluate their main symptoms. Fatigue, emotional disorders, sleep disorders, cognitive impairments, dyspnea, physical activity, quality of life and pain were analyzed. The patients were reassessed after three years. The same scales, indexes and questionnaires were also sent to a control group of 40 volunteers of the same age and sex as the cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with long COVID who have been attended at the Internal Medicine Department at the Hospital Universitario Río Hortega from Valladolid', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients older than 18 years old and younger than 75 years old\n* patients who accepted to participate in the study\n* patients who have had COVID acute infection\n* patients who have long COVID (cases)\n\nExclusion Criteria:\n\n* patients who refused to participate in the study at any time of the study\n* patients whose diagnosis of long COVID was revoked during the study (cases)'}, 'identificationModule': {'nctId': 'NCT06879535', 'briefTitle': 'Long-term Symptomatic Follow-up of Patients with Long COVID Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hospital del Rio Hortega'}, 'officialTitle': 'ESTUDIO DE APLICACIÓN DE ESCALAS PARA VALORACIÓN SINTOMÁTICA DEL SÍNDROME DE COVID PERSISTENTE', 'orgStudyIdInfo': {'id': '21-PI197'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients diagnosed with long COVID'}, {'label': 'Controls', 'description': 'Patients who have had COVID acute infection without developing long COVID'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47012', 'city': 'Valladolid', 'state': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Universitario Río Hortega', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital del Rio Hortega', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Médico Licenciado Especialista en Anestesiología y Reanimación', 'investigatorFullName': 'Andrés Carrascosa Gil', 'investigatorAffiliation': 'Hospital del Rio Hortega'}}}}