Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-27 @ 3:09 AM
Study NCT ID:
NCT05713292
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2023-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pirfenidone in Adult Hospitalized Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-29', 'studyFirstSubmitDate': '2023-01-01', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection', 'timeFrame': '1 month', 'description': '1. Change of total lung lesion volume on Chest CT from enrollment to 1 month follow up\n2. DLCO% pred at 1 month follow up'}], 'secondaryOutcomes': [{'measure': 'distance walked in 6 Minutes (6MWD)', 'timeFrame': 'at the 1 month and 3 months follow-up vist', 'description': 'the difference between intervention group and placebo group'}, {'measure': 'the EuroQol five-dimension five-level (EQ-5D-5L)', 'timeFrame': 'at the 1 month and 3 months follow-up vist', 'description': 'the difference between intervention group and placebo group'}, {'measure': 'Medical Research Council (mMRC) dyspnoea scale', 'timeFrame': 'at the 1 month and 3 months follow-up vist', 'description': 'the difference of mMRC score between intervention group and placebo group'}, {'measure': 'difference of forced vital capacity (FVC) between two groups', 'timeFrame': 'at the 1 month and 3 months follow-up vist', 'description': 'the difference of actual and predicted value between intervention group and placebo group'}, {'measure': 'difference of total lung capacity (TLC) between two groups', 'timeFrame': 'at the 1 month and 3 months follow-up vist', 'description': 'the difference of actual and predicted value between intervention group and placebo group'}, {'measure': 'difference of DLCO between two groups', 'timeFrame': 'at the 3 months follow-up vist', 'description': 'the difference of actual and predicted value between intervention group and placebo group'}, {'measure': 'incidence of adverse event', 'timeFrame': 'within 2 months after enrollment', 'description': 'the difference of adverse event frequency between intervention group and placebo group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Pneumonia']}, 'descriptionModule': {'briefSummary': 'This center intends to conduct a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects Age ≥ 18 Willing and able to provide written informed consent\n* SARS-CoV-2 infection confirmed by PCR test/antigen dectection or positive serologies\n* Time of illness onset ≥8 days\n* Have findings consistent with interstitial lung disease found on CT scan\n* Willing not use other investigational agents of anti-fibrosis\n\nExclusion Criteria:\n\n* Pre-existing severe liver disease\n* Pre-existing severe chronic kidney disease\n* Pre-existing interstitial lung disease\n* Pre-existing severe COPD or other structural lung disease\n* Receiving invasive mechanical ventilation\n* Currently Pregnant or Breast Feeding\n* Poor baseline health conditoin\n* Disability to complete lung function test\n* Receiving pirfenidone wthin half-year'}, 'identificationModule': {'nctId': 'NCT05713292', 'briefTitle': 'Pirfenidone in Adult Hospitalized Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pirfenidone in Adult Hospitalized Patients With COVID-19.', 'orgStudyIdInfo': {'id': 'CAP-China Pirfenidone'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pirfenidone', 'description': 'Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months', 'interventionNames': ['Drug: Pirfenidone Oral Product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months', 'interventionNames': ['Drug: Pirfenidone placebo']}], 'interventions': [{'name': 'Pirfenidone Oral Product', 'type': 'DRUG', 'description': 'Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months', 'armGroupLabels': ['Pirfenidone']}, {'name': 'Pirfenidone placebo', 'type': 'DRUG', 'description': 'Pirfenidone placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Capital Medical University', 'investigatorFullName': 'Bin Cao', 'investigatorAffiliation': 'Capital Medical University'}}}}