Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-02-04 @ 12:36 AM
Study NCT ID:
NCT05648734
Status:
COMPLETED
Last Update Posted:
2022-12-13
First Post:
2022-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-Inflammatory and Anti-Fibrotic Drugs in Post COVID-19 Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], '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': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D005355', 'term': 'Fibrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D003078', 'term': 'Colchicine'}, {'id': 'C093844', 'term': 'pirfenidone'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-11', 'studyFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2022-12-11', 'lastUpdatePostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Functions Test', 'timeFrame': '8 weeks', 'description': 'Change in FVC from 1 month to 3 months follow up after hospital discharge'}, {'measure': 'Radiological scoring', 'timeFrame': '8 weeks', 'description': 'Change in Chest CT Severity Scoring (Chest CT-SS) from 1 month to 3 months follow up after hospital discharge compared to baseline CT Chest scan'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-COVID-19 Syndrome', 'Lung Fibrosis']}, 'descriptionModule': {'briefSummary': 'In this study we aim to evaluate the radiological and functional changes in post-acute covid-19 pulmonary fibrosis patients in relation to anti-inflammatory and/or antifibrotic drugs prescribed during and after covid-19 pneumonia.', 'detailedDescription': 'This study is a prospective and retrospective cohort study in which post COVID-19 patients who are following up at post COVID-19 clinic are evaluated regarding presence and degree of Post COVID-19 Pulmonary Fibrosis (PCPF) in relation to anti-inflammatory and/or anti-fibrotic drugs.\n\nAdult patients who have COVID-19 pneumonia confirmed either by RT-PCR or radiologically by CT scan and according to WHO severity classification are (Moderate, severe, or critical) and has received either:\n\n* Corticosteroids alone (≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge) - Group A.\n* Corticosteroids in combination with Colchicine (1 mg/day for ≥ 10 days) - Group B.\n* Corticosteroids in combination with Pirfenidone (267 mg TID for ≥ 14 days) - Group C.\n* Corticosteroids in combination with Colchicine and Pirfenidone (for ≥ 14 days) - Group D.\n\nPulmonary function test: Spirometry: measurement of lung volumes and capacities (forced expiratory volume in first second FEV1, Forced Vital Capacity FVC, FEV1/FVC and FEF25/75) after 1 month and 3 months of the onset of symptoms.\n\nRadiological scoring: Baseline High resolution CT scan of the chest will be performed at baseline, 1 month and 3 months after onset of symptoms. Chest CT-Severity Scoring (Chest CT-SS) for assessing COVID-19 burden on the initial scan will be calculated. This score uses lung opacification as a surrogate for extension of the disease in the lungs. According to the anatomic structure, the 18 segments of both lungs were divided into 20 regions, in which the posterior apical segment of the left upper lobe was subdivided into apical and posterior segmental regions, whereas the anteromedial basal segment of the left lower lobe was subdivided into anterior and basal segmental regions. The lung opacities in all the 20 lung regions were subjectively evaluated on chest CT images using a system attributing score of 0, 1, and 2 if parenchymal opacification involved 0%, less than 50%, or equal to or more than 50% of each region, respectively. The CT-SS was defined as the sum of the individual scores in the 20 lung segment regions, which may range from 0 to 40 points'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective cohort study in which post COVID-19 patients who are following up at post COVID-19 clinic are evaluated regarding presence and degree of Post COVID-19 Pulmonary Fibrosis (PCPF) in relation to anti-inflammatory and/or anti-fibrotic drugs.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who have COVID-19 pneumonia confirmed either by RT-PCR or radiologically by CT scan and according to WHO severity classification are (Moderate, severe, or critical) and has received either: Corticosteroids alone.\n* Corticosteroids in combination with Colchicine.\n* Corticosteroids in combination with Pirfenidone.\n* Corticosteroids in combination with Colchicine and Pirfenidone.\n\nExclusion Criteria:\n\n* None COVID-19 pneumonia.\n* Patients with previous parenchymal lung disease.\n* Patients receiving anti-fibrotic or anti-inflammatory drugs due to other chronic disease.\n* Patients who received anti-fibrotic and or ant inflammatory drugs for duration and or doses less than presumed or those who reported noncompliance to treatment.\n* Patients with uncontrolled comorbidities.\n* Patients who develop severe intolerable side effects or derangement of liver enzymes more than 5 folds.\n* Pregnant ladies with COVID-19 pneumonia.'}, 'identificationModule': {'nctId': 'NCT05648734', 'briefTitle': 'Anti-Inflammatory and Anti-Fibrotic Drugs in Post COVID-19 Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Impact of Anti-Inflammatory and Anti-Fibrotic Drugs on Post-acute COVID-19 Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'MD.21.09.526 - 2021/09/12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Patients received Corticosteroids only', 'interventionNames': ['Drug: Corticosteroids alone']}, {'label': 'Group B', 'description': 'Patients received Corticosteroids in combination with Colchicine', 'interventionNames': ['Drug: Corticosteroids + Colchicine']}, {'label': 'Group C', 'description': 'Patients received Corticosteroids in combination with Pirfenidone', 'interventionNames': ['Drug: Corticosteroids + Pirfenidone']}, {'label': 'Group D', 'description': 'Patients received Corticosteroids in combination with Colchicine and Pirfenidone', 'interventionNames': ['Drug: Corticosteroids + Colchicine + Pirfenidone for ≥ 14 days']}], 'interventions': [{'name': 'Corticosteroids alone', 'type': 'DRUG', 'otherNames': ['Solupred', 'Disperlone', 'Methabiogen', 'Epicopred'], 'description': '(≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge)', 'armGroupLabels': ['Group A']}, {'name': 'Corticosteroids + Colchicine', 'type': 'DRUG', 'description': '(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days)', 'armGroupLabels': ['Group B']}, {'name': 'Corticosteroids + Pirfenidone', 'type': 'DRUG', 'otherNames': ['Corticosteroids + Pirfinix'], 'description': '(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days)', 'armGroupLabels': ['Group C']}, {'name': 'Corticosteroids + Colchicine + Pirfenidone for ≥ 14 days', 'type': 'DRUG', 'description': '(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days)', 'armGroupLabels': ['Group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Amina Abdel Maksoud, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University, Faculty of Medicine'}, {'name': 'Dalia Fahmy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University, Faculty of Medicine'}, {'name': 'Aida Yousef, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University, Faculty of Medicine'}, {'name': 'Mohamed Tohlob, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University, Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Anonymous'd individual data will be available with the corresponding author on reasonable request"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}