Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-29 @ 12:40 AM
Study NCT ID:
NCT05196451
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2022-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-time Intervention in Post-Covid Syndrome Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-20', 'size': 782975, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-20T18:16', 'hasProtocol': True}, {'date': '2022-02-23', 'size': 623039, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-23T05:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Functioning', 'timeFrame': 'Immediately after intervention (time T1)', 'description': 'Physical Functioning subscale from the SF-36 inventory. The SF-36 comprises a total of 36 items on subjective mental, social and physical health, which are assigned to 8 dimensions. Scale ranging from 0 (poor quality of life) to 100 (best)'}], 'secondaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': 'Immediately after intervention (time T1)', 'description': 'Chalder Fatigue Questionnaire (CFQ), total sum score. Range from 0-33, higher scores means more fatigue.'}, {'measure': 'Fatigue', 'timeFrame': 'At 12 months follow-up (time T2)', 'description': 'Chalder fatigue questionnaire, total sum score'}, {'measure': 'Depression/anxiety', 'timeFrame': 'Immediately after intervention (time T1)', 'description': 'Hospital Anxiety and Depresssion Scale, total score. Higher scores means more depression/anxiety symptoms.'}, {'measure': 'Depression/anxiety', 'timeFrame': 'At 12 months follow-up (time T2)', 'description': 'Hospital Anxiety and Depresssion Scale, total score'}, {'measure': 'Adverse effects', 'timeFrame': 'Immediately after intervention (time T1)', 'description': 'Self-invented questionnaire on adverse effects'}, {'measure': 'Adverse effects', 'timeFrame': 'At 12 months follow-up (time T2)', 'description': 'Self-invented questionnaire on adverse effects'}, {'measure': 'Physical Functioning', 'timeFrame': 'At 12 months follow-up (time T2)', 'description': 'Physical Functioning subscale from the SF-36 inventory'}, {'measure': 'Recovery from PIFS', 'timeFrame': 'Immediately after intervention (time T1)', 'description': 'Recovery from post-infective fatigue syndrome (PIFS)'}, {'measure': 'Recovery from PIFS', 'timeFrame': 'At 12 months follow-up (time T2)', 'description': 'Recovery from post-infective fatigue syndrome (PIFS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '39699896', 'type': 'DERIVED', 'citation': 'Nerli TF, Selvakumar J, Cvejic E, Heier I, Pedersen M, Johnsen TL, Wyller VBB. Brief Outpatient Rehabilitation Program for Post-COVID-19 Condition: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450744. doi: 10.1001/jamanetworkopen.2024.50744.'}]}, 'descriptionModule': {'briefSummary': "The present study is a 2-arm pragmatic randomised controlled trial (RCT) in which 310 patients who suffer from post-Covid syndrome are randomised to either a short-time outpatient-based rehabilitation program (the intervention) or care as usual in a 1:1 ratio. Assessments will take place immediately before randomisation (T0), after intervention or care as usual (T1), and 6 months after T1 (T2). Patients will be recruited from General Practitioners (GP's) as well as social media and self-referral to the involved institutions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fulfils pragmatic diagnostic criteria of idiopathic post-Covid syndrome: a) Confirmed acute Covid-19 by a positive PCR for SARS-CoV-2; b) Persistent symptoms at least 3 months following acute Covid-19 without symptom-free interval; c) Functional disability to an extent that interrupts all or a majority of normal activities (such as work/school attendance, physical exercise, social activities, etc.)\n* Lives in one of the following Norwegian counties: Oslo, Viken, Innlandet, Vestfold og Telemark, Agder\n* Informed consent to participation\n\nExclusion criteria\n\n* Other chronic illnesses or demanding life situations that might explain persistent symptoms and disability\n* Sustained organ damage (lung, heart, brain) following acute, serious Covid-19\n* Bedridden\n* Insufficient command of Norwegian language'}, 'identificationModule': {'nctId': 'NCT05196451', 'acronym': 'SIPCOV', 'briefTitle': 'Short-time Intervention in Post-Covid Syndrome Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Short-time Behavioural Intervention in Post-Covid Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '21/12248'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Short-time rehabilitation', 'description': 'The intervention consists of an individualized numbers of outpatient encounters (min. 2, max. 8) with medical doctors and physiotherapists at Kysthospitalet, Stavern, Norway. The encounters aim to foster a rehabilitation process based upon principles from Cognitive Behavioral Therapy (CBT)', 'interventionNames': ['Behavioral: Rehabilitation based on CBT principles']}, {'type': 'NO_INTERVENTION', 'label': 'Care as usual'}], 'interventions': [{'name': 'Rehabilitation based on CBT principles', 'type': 'BEHAVIORAL', 'description': 'Cf. arm description', 'armGroupLabels': ['Short-time rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1170', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Vegard Bratholm Wyller', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Vegard B Wyller', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Akershus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Vegard Wyller', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}