Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2026-01-10 @ 4:19 AM
Study NCT ID:
NCT05323318
Status:
UNKNOWN
Last Update Posted:
2023-03-14
First Post:
2022-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropsychological Sequelae and Long COVID-19 Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-12', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of fatigue in patients with post-COVID-19 depression and/or anxiety', 'timeFrame': '6-9 months', 'description': 'Fatigue will be assessed with the Chalder fatigue scale:\n\n\\- Global score (0-33), that also spans two dimensions-physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11). This is a Likert scoring system that allows for means and distributions to be calculated for both the global total as well as the two sub-scales.\n\nDepression and anxiety will be assessed with the Hospital Anxiety and Depression Scale\n\n* Depression HADS subscale scoring: Normal 0-7; Boderline abnormal 8-10; Abnormal 11-21\n* Anxiety HADS subscale scoring: Normal 0-7; Borderline 8-10; Abnormal 11-21'}, {'measure': 'Prevalence of fatigue in patients with post-COVID-19 post-traumatic stress disorder', 'timeFrame': '6-9 months', 'description': 'Fatigue will be assessed with the Chalder fatigue scale (global and binary score).\n\nPTSD will be assessed with the Post-Traumatic Stress Syndrome 14 Questions Inventory (PTSS-14) adapted to COVID-19:\n\n\\- Positive case between 46-98 points'}], 'secondaryOutcomes': [{'measure': 'Impact of post-COVID-19 fatigue in quality of life.', 'timeFrame': '6-9 months', 'description': 'Fatigue will be assessed with the Chalder fatigue scale (binary score and global score).\n\nQuality of live will be assessed by the original EQ-5D questionnaire, that comprises two parts:\n\n\\- EQ-5D-3L, health state classification scheme of five items (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each having three alternatives (1= no problems, 2= moderate problems, and 3= severe problems). Calculating a single index score combines these five dimensions.\n\nThe index value of a particular health state thus indicates the preference for being in that health state in relation to death, which has been set equal to 0 and best possible health (eg, no problems on any of the five items) which has been set to 1.0.\n\n\\- EQ VAS, a visual analog scale to health state ranging from 0 (worst possible health state) to 100 (best possible health state).'}, {'measure': 'Impact of post-COVID-19 neuropsychological sequelae in quality of life', 'timeFrame': '6-9 months', 'description': 'Evaluate if the positive cases for anxiety, depression and/or PTSD have lower quality of live (The tools will be the same of previous outcomes).'}, {'measure': 'Evaluate if neuropsychological are associated with severity of acute COVID-19', 'timeFrame': '6-9 months', 'description': 'Depression and anxiety will be assessed with the Hospital Anxiety and Depression Scale\n\n* Depression HADS subscale scoring: Normal 0-7; Boderline abnormal 8-10; Abnormal 11-21\n* Anxiety HADS subscale scoring: Normal 0-7; Borderline 8-10; Abnormal 11-21\n\nPosttraumatic Stress Symptoms-14 instrument, adapted in this protocol for COVID-19 survivors:\n\n\\- PTSS 14 scoring \\> 45 points\n\nAcute COVID-19 severity will be categorized as mild illness (mild symptoms without the radiographic appearance of pneumonia), pneumonia (having symptoms and the radiographic evidence of pneumonia, with no requirement for supplemental oxygen), severe pneumonia (having pneumonia, including one of the following: respiratory rate \\> 30 breaths/minute; severe respiratory distress; or SpO2 ≤ 93% on room air at rest), and critical cases (e.g. respiratory failure requiring mechanical ventilation or nasal high flow oxygen, septic shock, other organ failure occurrence or admission into the ICU).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2, fatigue, psychological disorders'], 'conditions': ['Anxiety Depression', 'Post Traumatic Stress Disorder', 'Mental Fatigue', 'COVID-19', 'Fatigue Syndrome, Chronic']}, 'referencesModule': {'references': [{'pmid': '23748906', 'type': 'BACKGROUND', 'citation': 'Ferreira LN, Ferreira PL, Pereira LN, Oppe M. The valuation of the EQ-5D in Portugal. Qual Life Res. 2014 Mar;23(2):413-23. doi: 10.1007/s11136-013-0448-z. Epub 2013 Jun 8.'}, {'pmid': '25559796', 'type': 'BACKGROUND', 'citation': 'Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.'}, {'pmid': '8463991', 'type': 'BACKGROUND', 'citation': 'Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147-53. doi: 10.1016/0022-3999(93)90081-p.'}, {'pmid': '30285773', 'type': 'BACKGROUND', 'citation': 'Rasa S, Nora-Krukle Z, Henning N, Eliassen E, Shikova E, Harrer T, Scheibenbogen C, Murovska M, Prusty BK; European Network on ME/CFS (EUROMENE). Chronic viral infections in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). J Transl Med. 2018 Oct 1;16(1):268. doi: 10.1186/s12967-018-1644-y.'}, {'pmid': '33528827', 'type': 'RESULT', 'citation': 'Simani L, Ramezani M, Darazam IA, Sagharichi M, Aalipour MA, Ghorbani F, Pakdaman H. Prevalence and correlates of chronic fatigue syndrome and post-traumatic stress disorder after the outbreak of the COVID-19. J Neurovirol. 2021 Feb;27(1):154-159. doi: 10.1007/s13365-021-00949-1. Epub 2021 Feb 2.'}, {'pmid': '32738287', 'type': 'RESULT', 'citation': 'Mazza MG, De Lorenzo R, Conte C, Poletti S, Vai B, Bollettini I, Melloni EMT, Furlan R, Ciceri F, Rovere-Querini P; COVID-19 BioB Outpatient Clinic Study group; Benedetti F. Anxiety and depression in COVID-19 survivors: Role of inflammatory and clinical predictors. Brain Behav Immun. 2020 Oct;89:594-600. doi: 10.1016/j.bbi.2020.07.037. Epub 2020 Jul 30.'}, {'pmid': '38241071', 'type': 'DERIVED', 'citation': 'Pires L, Reis C, Mesquita Facao AR, Moniri A, Marreiros A, Drummond M, Berger-Estilita J. Fatigue and Mental Illness Symptoms in Long COVID: Protocol for a Prospective Cohort Multicenter Observational Study. JMIR Res Protoc. 2024 Jan 19;13:e51820. doi: 10.2196/51820.'}]}, 'descriptionModule': {'briefSummary': 'An association of fatigue with post-viral neuropsychological disturbs has been reported. Among patients hospitalized with COVID-19 there is an increased incidence of anxiety and depression symptoms. In addition, a quarter of patients experience at least mild symptoms of acute post traumatic stress disorder. (Mazza, M. G. et al 2020). The prevalence of chronic fatigue syndrome had a correlation with post-traumatic stress disorder (PTSD) in a study conducted after the outbreak of the COVID-19 in Iran (Silmani et al, 2021), that showed 5.8% of subjects suffering from PTSD after 6 months of SARS-CoV-2 infection onset.\n\nIn this Study we propose to use a tool to quantify the degree of physical and psychological fatigue in post-COVID-19 patients, and assess the correlation of fatigue with the neuropsychiatric sequelae in hospitalized and non hospitalized patients.', 'detailedDescription': 'This study will address the neuropsychiatric sequelae that remain for at least 6 months after SARS-CoV-2 acute infection, as depression, anxiety and/or post-traumatic stress disorder.\n\nThe patiensts will be assessed at the post-COVID-19 outpatient clinics of five Portuguese Hospitals. In the first visit (T1) will be collected the demographic characteristics; the medical history; and the screening of acute disease symptoms and severity. In the second visit (T2), the time frame will be at least 6 months after the positive test and no longer than 9 months, a set of structured questionnaires will be provided, including: the Chalder Fatigue Scale, Anxiety and Depression Hospital Scale (HADS), The Posttraumatic Stress Symptoms-14 (PTSS-14) adapted to COVID-19 and the EuroQol 5-Dimensions (EQ-5D).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted in five Portuguese Hospitals, Universitary and district, in which a follow-up post-COVID-19 medical consultation has been implemented', 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥18 years;\n* Previous COVID-19 at least six months after the diagnosis duly documented in the clinical record;\n* Persistent symptoms after cure criteria defined by WHO Symptomatic patients that attend the post-COVID-19 follow-up consultation of the study centres.\n* SARS-CoV-2 RNA confirmed by a positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab.\n* SARS-CoV-2 antigen confirmed on a nasopharyngeal swab, by a healthcare professional.\n\nExclusion Criteria:\n\n* Patients with PTSD previous diagnosis\n* Severe psychiatric disorders documented in the clinical record\n* Patients not able to respond the questionnaire\n* Patients who had a concomitant severe neurological disorder\n* Clinical and radiological diagnosis of Stroke with sequelae\n* Clinical diagnosis of Alzheimer's Disease\n* Clinical diagnosis of Parkinson's disease\n* Patients with persistent fatigue symptoms in the 6 months before SARS-CoV 2 infection"}, 'identificationModule': {'nctId': 'NCT05323318', 'acronym': 'PostCoV2Psy', 'briefTitle': 'Neuropsychological Sequelae and Long COVID-19 Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar Universitario do Algarve'}, 'officialTitle': 'Neuropsychological Sequelae as a Risk Factor for Long COVID-19 Fatigue', 'orgStudyIdInfo': {'id': '141/21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neuropsychological Sequelae', 'description': 'Post-COVID-19 symptomatic patients with neuropsychological sequelae', 'interventionNames': ['Other: Neuropsychological Sequelae']}, {'label': 'Without Neuropsychological Sequelae', 'description': 'Post-COVID-19 symptomatic patients Without neuropsychological sequelae'}], 'interventions': [{'name': 'Neuropsychological Sequelae', 'type': 'OTHER', 'description': 'Neuropsychological Sequelae after SARS-CoV-2 symtomatic infection', 'armGroupLabels': ['Neuropsychological Sequelae']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8500-322', 'city': 'Alvor', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'ANA FONTES, PHD', 'role': 'CONTACT', 'email': 'anafontes@grupohpa.com', 'phone': '282420400'}, {'name': 'Ligia Pires, MD', 'role': 'CONTACT'}, {'name': 'Ligia Pires, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Armin Bidarian, PHD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Particular de Alvor', 'geoPoint': {'lat': 37.12994, 'lon': -8.59174}}, {'zip': '2720-276', 'city': 'Amadora', 'status': 'COMPLETED', 'country': 'Portugal', 'facility': 'Hospital Professor Doutor Fernando Fonseca (Hff)', 'geoPoint': {'lat': 38.75382, 'lon': -9.23083}}, {'zip': '8000-386', 'city': 'Faro', 'status': 'COMPLETED', 'country': 'Portugal', 'facility': 'Hospital de Faro (Chua)', 'geoPoint': {'lat': 37.01869, 'lon': -7.92716}}, {'zip': '8500-338', 'city': 'Portimão', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Ligia S Pires, MD', 'role': 'CONTACT', 'email': 'alves1029@hotmail.com', 'phone': '+351282450300', 'phoneExt': '35115'}, {'name': 'Inês Simões, MD', 'role': 'CONTACT', 'email': 'inesgsimoes@gmail.com', 'phone': '+351282450300', 'phoneExt': '43066'}, {'name': 'Ligia Pires, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Claudia Reis, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rita Falcão, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rute Martins, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de Portimao', 'geoPoint': {'lat': 37.13856, 'lon': -8.53775}}, {'zip': '4520-211', 'city': 'Santa Maria da Feira', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Ana Sofia Barroso, MD', 'role': 'CONTACT', 'email': 'anasofiabarroso@gmail.com', 'phone': '+351 256 379 700'}, {'name': 'Jorge Ferreira, Prof', 'role': 'CONTACT', 'email': 'pneumologia@chedv.min-saude.pt', 'phone': '+351 256 379 700'}, {'name': 'Ana Sofia Barroso, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jorge Ferreira, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lucia Gonzalez, Nurse', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Sao Sebastiao (Chedv)', 'geoPoint': {'lat': 40.92726, 'lon': -8.54839}}, {'zip': '2600-009', 'city': 'Vila Franca de Xira', 'status': 'SUSPENDED', 'country': 'Portugal', 'facility': 'Hospital de Vila Franca de Xira (Hvfx)', 'geoPoint': {'lat': 38.95525, 'lon': -8.98966}}], 'centralContacts': [{'name': 'Ligia Pires, MD', 'role': 'CONTACT', 'email': 'alves1029@hotmail.com', 'phone': '+351282450300', 'phoneExt': '43168'}, {'name': 'Inês Simões, MD', 'role': 'CONTACT', 'email': 'inesgsimoes@gmail.com', 'phone': '+351282450300', 'phoneExt': '43066'}], 'overallOfficials': [{'name': 'Ligia Pires, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centro Hospitalar Universitario do Algarve'}, {'name': 'Joana Berger, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitat Bern'}, {'name': 'Ligia Pires, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Hospitalar Universitario do Algarve'}, {'name': 'Marta Drummond, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade do Porto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar Universitario do Algarve', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade do Algarve', 'class': 'OTHER'}, {'name': 'Universidade do Porto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ligia Pires', 'investigatorAffiliation': 'Centro Hospitalar Universitario do Algarve'}}}}