Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT04941105
Status:
COMPLETED
Last Update Posted:
2023-04-21
First Post:
2021-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577155', 'term': 'evolocumab'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death from any cause or need for intubation', 'timeFrame': 'during hospitalization, up to 30 days', 'description': 'Indication for intubation determined individually for each patient and clinical status'}], 'secondaryOutcomes': [{'measure': 'Change in serum interleukin-6 concentration from day 0 to day 7 and day 30', 'timeFrame': '7 and 30 days from randomization'}, {'measure': 'Death from any cause', 'timeFrame': 'during hospitalization, up to 30 days', 'description': 'Death from any cause during hospitalization.'}, {'measure': 'Need for intubation', 'timeFrame': 'during hospitalization, up to 30 days', 'description': 'Indication for intubation determined individually for each patient and clinical status'}, {'measure': 'Duration of oxygen therapy', 'timeFrame': 'during hospitalization, up to 30 days', 'description': 'Defined as the number of days of oxygen therapy (including all methods of oxygen therapy)'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'during hospitalization, up to 30 days', 'description': 'Defined as the number of days that pass between the day of hospital admission and discharge or death.'}, {'measure': 'Days of intubation', 'timeFrame': 'during hospitalization, up to 30 days', 'description': 'Defined as the number of days between intubation and extubation'}, {'measure': 'Time with Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC)', 'timeFrame': 'during hospitalization, up to 30 days', 'description': 'Defined as the number of days between initiation and cessation of Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-CoV-2 Pneumonia', 'PCSK9 inhibitor'], 'conditions': ['Sars-CoV-2 Infection']}, 'referencesModule': {'references': [{'pmid': '36653090', 'type': 'DERIVED', 'citation': 'Navarese EP, Podhajski P, Gurbel PA, Grzelakowska K, Ruscio E, Tantry U, Magielski P, Kubica A, Niezgoda P, Adamski P, Junik R, Przybylski G, Pilaczynska-Cemel M, Rupji M, Specchia G, Pinkas J, Gajda R, Gorog DA, Andreotti F, Kubica J. PCSK9 Inhibition During the Inflammatory Stage of SARS-CoV-2 Infection. J Am Coll Cardiol. 2023 Jan 24;81(3):224-234. doi: 10.1016/j.jacc.2022.10.030.'}]}, 'descriptionModule': {'briefSummary': 'The IMPACT-SIRIO 5 is a randomized, double-blind, phase III clinical trial aimed to evaluate safety and efficacy of PCSK9 inhibition on clinical outcome in patients during the inflammatory stage of the COVID-19. During the hospitalization participants will be randomized in a 1:1 ratio to either receive PCSK9 inhibitor (evolocumab) or to receive placebo (saline solution). Furthermore, all people included in the study will be treated in accordance to the latest recommendations on the treatment of patients infected with SARS-CoV-2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent for participation in the study\n2. Male and female age 18 or more at the time of signing the informed consent\n3. SARS-CoV-2 infection confirmed by Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR)\n4. COVID-19 pneumonia with a typical radiological changes\n5. PaO2/FIO2 ratio less than or equal to 300\n6. COVID-19 Pneumonia in cytokine storm with elevated serum level of interleukin-6\n\nExclusion Criteria:\n\n1. Use of fibrates other than fenofibrate or fenofibric acid\n2. Known active infections or other clinical condition that contraindicate PCSK9 inhibitors\n3. Known systemic hypersensitivity to PCSK9 inhibitors\n4. Estimated glomerular filtration rate \\<30 ml/min/1.73 m2\n5. Absolute neutrophil count (ANC) less than 2000/mm3\n6. A platelet count less than 50000/mm3\n7. Creatine kinase (CK) greater than 3x upper limit of normal (ULN)\n8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3x upper limit of normal (ULN)\n9. Not expected to survive for more than 48 hours from screening\n10. Unrelated co-morbidity with life expectancy \\<3 months.\n11. Pregnancy\n12. Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study\n13. Patient being treated with other immunomodulators (except for glucocorticoids).\n14. Patient included in any other interventional trial.'}, 'identificationModule': {'nctId': 'NCT04941105', 'acronym': 'IMPACT-SIRIO 5', 'briefTitle': 'Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Collegium Medicum w Bydgoszczy'}, 'officialTitle': 'Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19: the Randomized, Double-blind, Phase III IMPACT-SIRIO 5 Study.', 'orgStudyIdInfo': {'id': 'IMPACT-SIRIO 5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCSK9 inhibitor (evolocumab)', 'description': '140 mg of evolocumab as a single subcutaneous injection and standard of care accordance to the latest recommendations', 'interventionNames': ['Drug: Evolocumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Care', 'description': '1 ml of 0,9% saline solution as a single subcutaneous injection. Patients will be treated in accordance to the latest recommendations on caring for patients infected with SARS-CoV-2.', 'interventionNames': ['Drug: Saline solution']}], 'interventions': [{'name': 'Evolocumab', 'type': 'DRUG', 'description': 'A single subcutaneous administration of 140 mg evolocumab', 'armGroupLabels': ['PCSK9 inhibitor (evolocumab)']}, {'name': 'Saline solution', 'type': 'DRUG', 'description': 'A single subcutaneous injection of 1ml of 0,9% saline solution', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Antoni Jurasz University Hospital No. 1', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'overallOfficials': [{'name': 'Jacek Kubica, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland'}, {'name': 'Eliano Navarese, Md, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Collegium Medicum w Bydgoszczy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Cardiology and Internal Medicine', 'investigatorFullName': 'Jacek Kubica', 'investigatorAffiliation': 'Collegium Medicum w Bydgoszczy'}}}}