Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-01-02 @ 9:52 AM
Study NCT ID:
NCT04333550
Status:
UNKNOWN
Last Update Posted:
2020-05-04
First Post:
2020-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Desferal to Treat 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': 'D003676', 'term': 'Deferoxamine'}], 'ancestors': [{'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2020-04-01', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': 'up to 20 days', 'description': 'All cause of death'}], 'secondaryOutcomes': [{'measure': 'change in patients clinical manifestation', 'timeFrame': 'up to 20 days', 'description': 'Mild, Moderate or Severe'}, {'measure': 'change in patients PaO2', 'timeFrame': 'up to 20 days'}, {'measure': 'Length of hospitalization', 'timeFrame': 'up to 20 days', 'description': 'days'}, {'measure': 'C-reactive protein', 'timeFrame': 'up to 20 days'}, {'measure': 'lymphocyte count', 'timeFrame': 'up to 20 days'}, {'measure': 'length of intensive care unit stay', 'timeFrame': '1 to 20 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19, Deferoxamine'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '18552864', 'type': 'RESULT', 'citation': 'Drakesmith H, Prentice A. Viral infection and iron metabolism. Nat Rev Microbiol. 2008 Jul;6(7):541-52. doi: 10.1038/nrmicro1930.'}, {'pmid': '25076907', 'type': 'RESULT', 'citation': 'Nairz M, Haschka D, Demetz E, Weiss G. Iron at the interface of immunity and infection. Front Pharmacol. 2014 Jul 16;5:152. doi: 10.3389/fphar.2014.00152. eCollection 2014.'}, {'pmid': '10669330', 'type': 'RESULT', 'citation': 'Georgiou NA, van der Bruggen T, Oudshoorn M, Nottet HS, Marx JJ, van Asbeck BS. Inhibition of human immunodeficiency virus type 1 replication in human mononuclear blood cells by the iron chelators deferoxamine, deferiprone, and bleomycin. J Infect Dis. 2000 Feb;181(2):484-90. doi: 10.1086/315223.'}, {'pmid': '22187937', 'type': 'RESULT', 'citation': 'Vlahakos D, Arkadopoulos N, Kostopanagiotou G, Siasiakou S, Kaklamanis L, Degiannis D, Demonakou M, Smyrniotis V. Deferoxamine attenuates lipid peroxidation, blocks interleukin-6 production, ameliorates sepsis inflammatory response syndrome, and confers renoprotection after acute hepatic ischemia in pigs. Artif Organs. 2012 Apr;36(4):400-8. doi: 10.1111/j.1525-1594.2011.01385.x. Epub 2011 Dec 21.'}, {'pmid': '29619244', 'type': 'RESULT', 'citation': 'Wang H, Li Z, Niu J, Xu Y, Ma L, Lu A, Wang X, Qian Z, Huang Z, Jin X, Leng Q, Wang J, Zhong J, Sun B, Meng G. Antiviral effects of ferric ammonium citrate. Cell Discov. 2018 Mar 27;4:14. doi: 10.1038/s41421-018-0013-6. eCollection 2018.'}, {'pmid': '7811060', 'type': 'RESULT', 'citation': 'Cinatl J Jr, Cinatl J, Rabenau H, Gumbel HO, Kornhuber B, Doerr HW. In vitro inhibition of human cytomegalovirus replication by desferrioxamine. Antiviral Res. 1994 Sep;25(1):73-7. doi: 10.1016/0166-3542(94)90095-7.'}, {'pmid': '11886437', 'type': 'RESULT', 'citation': 'Visseren F, Verkerk MS, van der Bruggen T, Marx JJ, van Asbeck BS, Diepersloot RJ. Iron chelation and hydroxyl radical scavenging reduce the inflammatory response of endothelial cells after infection with Chlamydia pneumoniae or influenza A. Eur J Clin Invest. 2002 Mar;32 Suppl 1:84-90. doi: 10.1046/j.1365-2362.2002.0320s1084.x.'}, {'pmid': '8554902', 'type': 'RESULT', 'citation': 'Sappey C, Boelaert JR, Legrand-Poels S, Forceille C, Favier A, Piette J. Iron chelation decreases NF-kappa B and HIV type 1 activation due to oxidative stress. AIDS Res Hum Retroviruses. 1995 Sep;11(9):1049-61. doi: 10.1089/aid.1995.11.1049.'}, {'pmid': '25291189', 'type': 'RESULT', 'citation': 'Chang HC, Bayeva M, Taiwo B, Palella FJ Jr, Hope TJ, Ardehali H. Short communication: high cellular iron levels are associated with increased HIV infection and replication. AIDS Res Hum Retroviruses. 2015 Mar;31(3):305-12. doi: 10.1089/aid.2014.0169. Epub 2014 Oct 7.'}, {'pmid': '16787239', 'type': 'RESULT', 'citation': 'Meyer D. Iron chelation as therapy for HIV and Mycobacterium tuberculosis co-infection under conditions of iron overload. Curr Pharm Des. 2006;12(16):1943-7. doi: 10.2174/138161206777442164.'}, {'pmid': '8665150', 'type': 'RESULT', 'citation': 'Cinatl J, Scholz M, Weber B, Cinatl J, Rabenau H, Markus BH, Encke A, Doerr HW. Effects of desferrioxamine on human cytomegalovirus replication and expression of HLA antigens and adhesion molecules in human vascular endothelial cells. Transpl Immunol. 1995 Dec;3(4):313-20. doi: 10.1016/0966-3274(95)80017-4.'}, {'pmid': '10051178', 'type': 'RESULT', 'citation': 'Mabeza GF, Loyevsky M, Gordeuk VR, Weiss G. Iron chelation therapy for malaria: a review. Pharmacol Ther. 1999 Jan;81(1):53-75. doi: 10.1016/s0163-7258(98)00037-0.'}, {'pmid': '8067783', 'type': 'RESULT', 'citation': 'Weinberg GA. Iron chelators as therapeutic agents against Pneumocystis carinii. Antimicrob Agents Chemother. 1994 May;38(5):997-1003. doi: 10.1128/AAC.38.5.997.'}, {'pmid': '18369153', 'type': 'RESULT', 'citation': 'Paradkar PN, De Domenico I, Durchfort N, Zohn I, Kaplan J, Ward DM. Iron depletion limits intracellular bacterial growth in macrophages. Blood. 2008 Aug 1;112(3):866-74. doi: 10.1182/blood-2007-12-126854. Epub 2008 Mar 27.'}, {'pmid': '29719970', 'type': 'RESULT', 'citation': 'Giannakopoulou E, Pardali V, Zoidis G. Metal-chelating agents against viruses and parasites. Future Med Chem. 2018 Jun 1;10(11):1283-1285. doi: 10.4155/fmc-2018-0100. Epub 2018 May 3. No abstract available.'}, {'pmid': '1406879', 'type': 'RESULT', 'citation': 'Gordeuk V, Thuma P, Brittenham G, McLaren C, Parry D, Backenstose A, Biemba G, Msiska R, Holmes L, McKinley E, et al. Effect of iron chelation therapy on recovery from deep coma in children with cerebral malaria. N Engl J Med. 1992 Nov 19;327(21):1473-7. doi: 10.1056/NEJM199211193272101.'}, {'pmid': '28583206', 'type': 'RESULT', 'citation': 'Duchemin JB, Paradkar PN. Iron availability affects West Nile virus infection in its mosquito vector. Virol J. 2017 Jun 5;14(1):103. doi: 10.1186/s12985-017-0770-0.'}]}, 'descriptionModule': {'briefSummary': 'In this study, defined cases of COVID-19 with mild, moderate or severe pneumonia will be treated with standard treatment regimens in combination with IV injection of Deferoxamine. Improvement in clinical, laboratory and radiological manifestations will be evaluated in treated patient compared to control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of COVID-19 Disease,\n\nExclusion Criteria:\n\nPrevious history of allergy to Deferoxamin, Pregnancy, kidney dysfunction,'}, 'identificationModule': {'nctId': 'NCT04333550', 'briefTitle': 'Application of Desferal to Treat COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Kermanshah University of Medical Sciences'}, 'officialTitle': 'Application of Iron Chelator (Desferal) to Reduce the Severity of COVID-19 Manifestations', 'orgStudyIdInfo': {'id': '1398.1224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Desferal addition to standard treatment', 'interventionNames': ['Drug: Deferoxamine']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: standard treatment', 'interventionNames': ['Drug: Deferoxamine']}], 'interventions': [{'name': 'Deferoxamine', 'type': 'DRUG', 'description': 'Intravenous infusion of Deferoxamine', 'armGroupLabels': ['Experimental: Desferal addition to standard treatment', 'Experimental: standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '083', 'city': 'Kermanshah', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Yadollah Shakiba, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran', 'geoPoint': {'lat': 34.31417, 'lon': 47.065}}], 'centralContacts': [{'name': 'Alireza Ghaffarieh, MD', 'role': 'CONTACT', 'email': 'alirezaghaffariyeh@hotmail.com', 'phone': '+1-608-698-7334'}, {'name': 'Yadollah Shakiba, MD, PhD', 'role': 'CONTACT', 'email': 'yshakiba@gmail.com'}], 'overallOfficials': [{'name': 'Yadollah Shakiba, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran'}, {'name': 'Amir Kiani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kermanshah University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Yadollah Shakiba, MD, PhD', 'investigatorFullName': 'Dr. Yadollah Shakiba', 'investigatorAffiliation': 'Kermanshah University of Medical Sciences'}}}}