Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT04375202
Status:
TERMINATED
Last Update Posted:
2022-11-07
First Post:
2020-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colchicine in COVID-19: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003078', 'term': 'Colchicine'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}}, 'statusModule': {'whyStopped': 'Insufficient rate of patient accrual and newly available scientific evidence', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-05-03', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of entering the critical stage', 'timeFrame': '[1 month]', 'description': 'Comply with any of the followings:\n\n1. Respiratory failure occurs and requires mechanical ventilation;\n2. Patients combined with other organ failure need ICU monitoring and treatment\n3. Death'}], 'secondaryOutcomes': [{'measure': 'Trend of White blood cell count', 'timeFrame': '[up to 30 days]'}, {'measure': 'Change of the "Sequential Organ failure Assessment" (SOFA)', 'timeFrame': '[up to 30 days]'}, {'measure': 'Rate of biochemical criterion (CK, ALT, ferritin) recovery', 'timeFrame': '[up to 30 days]'}, {'measure': 'Rate of disease remission', 'timeFrame': '[up to 30 days]', 'description': 'Comply with any of the followings:\n\n1. No fever, cough and other symptoms;\n2. SPO2\\>94% or PaO2/FiO2 \\>350mmHg without oxygen inhalation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID', 'COVID-19', 'CORONAVIRUS', 'SARS-COV-2', 'COLCHICINE', 'IL-1'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32317220', 'type': 'BACKGROUND', 'citation': 'Perricone C, Triggianese P, Bartoloni E, Cafaro G, Bonifacio AF, Bursi R, Perricone R, Gerli R. The anti-viral facet of anti-rheumatic drugs: Lessons from COVID-19. J Autoimmun. 2020 Jul;111:102468. doi: 10.1016/j.jaut.2020.102468. Epub 2020 Apr 17.'}, {'pmid': '34658014', 'type': 'DERIVED', 'citation': 'Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.'}], 'seeAlsoLinks': [{'url': 'https://www.aifa.gov.it/sperimentazioni-cliniche-covid-19', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint.', 'detailedDescription': 'This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care versus current care.\n\nOne-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint. Secondary objectives are trend of White blood cell count, Change of the "Sequential Organ failure Assessment" (SOFA), Rate of biochemical criterion (CK, ALT,ferritin) recovery, Rate of disease remission and safety of Colchicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent for participation in the study\n* Virological diagnosis of SARS-CoV-2 infection (real-time PCR)\n* Hospitalized due to clinical/instrumental diagnosis of pneumonia\n* Oxygen saturation at rest in ambient air ≤94%\n* PaO2/FiO2 ratio of 350 to 200\n\nExclusion Criteria:\n\n* Known hypersensitivity to colchicine or its excipients\n* Severe diarrhea\n* Patients who cannot take oral therapy\n* Pregnant and lactating patients\n* Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) \\<30 mL / min)\n* Patients with kidney or liver damage \\[(AST or ALT\\> 5 times the normal limits in International Units (ULN)\\]; or are taking CYP3A4 enzyme - P glycoprotein inhibitors.\n* Known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician\n* Neutrophils \\<1.000 / mmc\n* Platelets \\<50.000 / mmc\n* Bowel diverticulitis or perforation\n* Patients already in ICU or requiring mechanical ventilation\n* Patients receiving Tocilizumab\n* Patients already enrolled in other clinical trials'}, 'identificationModule': {'nctId': 'NCT04375202', 'acronym': 'COLVID-19', 'briefTitle': 'Colchicine in COVID-19: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University Of Perugia'}, 'officialTitle': 'Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study', 'orgStudyIdInfo': {'id': '2020-001475-33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colchicine plus current care', 'description': 'Colchicine 0.5 mg three times a day if weight is less than 100 kg; 1 mg twice a day if weight is more than 100 kg for 30 days or up to discharge. Reduce based on gastrointestinal symptoms appearance at discretion of the Investigator.', 'interventionNames': ['Drug: Colchicine 1 MG Oral Tablet']}, {'type': 'NO_INTERVENTION', 'label': 'Current care alone', 'description': 'Current care'}], 'interventions': [{'name': 'Colchicine 1 MG Oral Tablet', 'type': 'DRUG', 'description': 'Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.', 'armGroupLabels': ['Colchicine plus current care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Associazione Italiana Pneumologi Ospedalieri', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Società Italiana di Reumatologia', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Of Perugia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof Roberto Gerli', 'investigatorAffiliation': 'University Of Perugia'}}}}