Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-27 @ 12:03 PM
Study NCT ID:
NCT05430503
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2022-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long COVID and Post-exertional Pulmonary Diffusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D004417', 'term': 'Dyspnea'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008176', 'term': 'Lung Volume Measurements'}, {'id': 'D013147', 'term': 'Spirometry'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2022-06-19', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined DLNO and DLCO changes after mild exercise', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'pulmonary gas exchange abnormalities in dyspneic long COVID subjects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Long COVID', 'Breathlessness', 'Exercise Intolerance', 'Alveolar Lung Disease', 'Pulmonary Gas Exchange']}, 'descriptionModule': {'briefSummary': 'Aim of investigators was to study whether abnormalities of lung diffusing capacity for nitric oxide (DLNO) and carbon monoxide (DLCO) in long COVID may have a clinical impact in relation to exercise intolerance.', 'detailedDescription': 'Prolonged recovery from acute coronavirus disease 2019 (long COVID) is characterized in about 30% of subjects from breathlessness and fatigue also during daily activities often associated to decreased lung diffusing capacity for carbon monoxide (DLCO) at rest. Aim of investigators was to study whether abnormalities of lung diffusing capacity for nitric oxide (DLNO) and DLCO in long COVID may have a clinical impact in relation to exercise intolerance. Combined DLNO and DLCO were simultaneously measured at rest and immediately after a short bout of treadmill walking in 32 dyspneic subjects ≥3 months after the COVID-19 acute phase. A group of healthy subjects served as a control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Caucasian subjects with a history of SARS CoV-2 infection confirmed by nasopharyngeal swab with real-time polymerase-chain reaction. They were referred to our pulmonary function laboratory after being tested negative for SARS-CoV-2, because of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.\n\nExclusion Criteria:\n\n* History of diseases potentially causing dyspnea or affecting pulmonary gas transport, i.e., bronchial asthma, lung bullous disease, chronic obstructive pulmonary disease, pulmonary interstitial fibrosis or vasculitis, hematological diseases, systemic collagen diseases, congestive heart failure, liver or renal diseases, and morbid obesity.'}, 'identificationModule': {'nctId': 'NCT05430503', 'acronym': 'Long_COVID_Ex', 'briefTitle': 'Long COVID and Post-exertional Pulmonary Diffusion', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy'}, 'officialTitle': 'Lung Diffusing Capacities for Nitric Oxide and Carbon Monoxide in Long COVID With Dyspnea at Rest and After Mild Exercise', 'orgStudyIdInfo': {'id': 'Long_COVID_Exer_DLNO_DLCO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Long COVID', 'description': "Caucasian subjects with a history of SARS CoV-2 infection confirmed by nasopharyngeal swab with real-time polymerase-chain reaction were included in the study. They were referred to investigators' pulmonary function laboratory after being tested negative for SARS-CoV-2, because of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.", 'interventionNames': ['Diagnostic Test: Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exercise']}, {'label': 'Healthy controls', 'description': 'Anthropometrically-matched healthy subjects, without history of COVID-19 and vaccinated against SARS-CoV-2 infection.', 'interventionNames': ['Diagnostic Test: Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exercise']}], 'interventions': [{'name': 'Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exercise', 'type': 'DIAGNOSTIC_TEST', 'description': 'DLNO and DLCO were measured at rest and 5-10 s after a bout of treadmill exercise simulating usual walking', 'armGroupLabels': ['Healthy controls', 'Long COVID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genoa', 'country': 'Italy', 'facility': 'Ospedale Policlinico San Martino IRCCS - S.S. Fisiopatologia Respiratoria', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Respiratory Pathophysiology', 'investigatorFullName': 'Giovanni Barisione', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy'}}}}