Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT04647604
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2020-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -
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': 'C568345', 'term': 'fish oil triglycerides'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2020-11-27', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in inflammatory biomarkers', 'timeFrame': '5 days', 'description': 'white blood cell counts'}, {'measure': 'Changes in inflammatory biomarkers', 'timeFrame': '5 days', 'description': 'CRP'}, {'measure': 'Changes in inflammatory biomarkers', 'timeFrame': '5 days', 'description': 'lipidomic profiling'}, {'measure': 'Changes in inflammatory biomarkers', 'timeFrame': '5 days', 'description': 'cytokines'}, {'measure': 'Changes in inflammatory biomarkers', 'timeFrame': '5 days', 'description': 'metabolomic profiling'}], 'secondaryOutcomes': [{'measure': 'Changes in proresolving mediators', 'timeFrame': '5 days', 'description': 'lipidomics'}, {'measure': 'Changes in fatty acids in the erythrocyte fraction', 'timeFrame': '5 days', 'description': 'fatty acid profile'}, {'measure': 'Changes in cardiac biomarkers', 'timeFrame': '5 days', 'description': 'Troponin, NTproBNP'}, {'measure': 'Changes in biomarkers of organ damage', 'timeFrame': '5 days', 'description': 'LD, creatinine'}, {'measure': 'Changes in thrombosis parameters', 'timeFrame': '5 days', 'description': 'platelet count, D-dimer,'}, {'measure': 'Changes in coagulation parameters', 'timeFrame': '5 days', 'description': 'fibrinogen'}, {'measure': 'Changes in markers of infection', 'timeFrame': '5 days', 'description': 'procalcitonin concentrations'}, {'measure': 'Changes in infection load', 'timeFrame': '5 days', 'description': 'SARS-CoV2-RNAemia'}, {'measure': 'Changes in clinical parameters', 'timeFrame': 'through study completion, on average 10 days', 'description': 'National Early Warning Score (NEWS2)'}, {'measure': 'Length of hospital stay', 'timeFrame': 'through study completion, on average 10 days', 'description': 'Days of hospital stay'}, {'measure': 'Complications', 'timeFrame': 'through study completion, on average 10 days', 'description': 'ICU need, mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Storm', 'COVID-19 infection', 'Omega-3 fatty acids', 'Inflammatory biomarkers', 'Omega-3 index'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '33505321', 'type': 'DERIVED', 'citation': 'Arnardottir H, Pawelzik SC, Ohlund Wistbacka U, Artiach G, Hofmann R, Reinholdsson I, Braunschweig F, Tornvall P, Religa D, Back M. Stimulating the Resolution of Inflammation Through Omega-3 Polyunsaturated Fatty Acids in COVID-19: Rationale for the COVID-Omega-F Trial. Front Physiol. 2021 Jan 11;11:624657. doi: 10.3389/fphys.2020.624657. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'A study on patients who are hospitalized and tested positive for COVID-19 or have a typical CT image of COVID-19 infection, to establish if omega-3 Polyunsaturated Fatty Acid (PUFA) supplementation by intravenous route is a possible treatment option in COVID-19 with minimal risks to the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed informed consent prior to any study specific procedures.\n2. Female and male patients ≥18 years of age.\n3. COVID-19 positive or typical CT image of COVID-19 infection.\n4. Clinical status requiring hospitalization.\n\nExclusion Criteria:\n\n1. According to Omegaven® contraindications (serious bleeding disorders, acute life-threatening condition, including acute shock, acute myocardial infarction, acute stroke, acute emboli, and coma).\n2. Known hypersensitivity to Omegaven® or any of the ingredients.\n3. Participation in any clinical research study evaluating an investigational medicinal product (IMP) within 3 months prior to screening.\n4. Pregnancy and breastfeeding.'}, 'identificationModule': {'nctId': 'NCT04647604', 'briefTitle': 'Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study', 'orgStudyIdInfo': {'id': '2020-002293-28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omega', 'description': 'Omegaven® (2 mL/kg/day, equivalent to 6 g Docosahexaenoic Acid (DHA)+Eicosapentaenoic Acid (EPA) in a 70 kg individual) once daily for 5 days', 'interventionNames': ['Drug: Omegaven®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium chloride (NaCl)', 'description': '2 mL/kg/day) once daily for 5 days', 'interventionNames': ['Drug: Sodium chloride']}], 'interventions': [{'name': 'Omegaven®', 'type': 'DRUG', 'description': 'A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.', 'armGroupLabels': ['Omega']}, {'name': 'Sodium chloride', 'type': 'DRUG', 'description': 'intravenously administered 2 mL/kg/day', 'armGroupLabels': ['Sodium chloride (NaCl)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Universitetssjuhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Magnus Bäck, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 9 months following article publication and finishing 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported will be shared, after deidentification, with researchers who provide a methodologically sound proposal.', 'accessCriteria': 'Study protocol will be published. Investigators interested in data should contact the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiology', 'investigatorFullName': 'Magnus Bäck', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}