NCT04333550

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1 covid19

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

April 1, 2020

Last Update Submit

April 30, 2020

Conditions

COVID-19

Keywords

COVID-19, Deferoxamine

Outcome Measures

Primary Outcomes (1)

  • Mortality rate

    All cause of death

    up to 20 days

Secondary Outcomes (6)

  • change in patients clinical manifestation

    up to 20 days

  • change in patients PaO2

    up to 20 days

  • Length of hospitalization

    up to 20 days

  • C-reactive protein

    up to 20 days

  • lymphocyte count

    up to 20 days

  • +1 more secondary outcomes

Study Arms (2)

Experimental: Desferal addition to standard treatment

EXPERIMENTAL
Drug: Deferoxamine

Experimental: standard treatment

EXPERIMENTAL
Drug: Deferoxamine

Interventions

DeferoxamineDRUG

Intravenous infusion of Deferoxamine

Experimental: Desferal addition to standard treatmentExperimental: standard treatment

Eligibility Criteria

Age3 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of COVID-19 Disease,

You may not qualify if:

  • Previous history of allergy to Deferoxamin, Pregnancy, kidney dysfunction,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran

Kermanshah, 083, Iran

RECRUITING

Related Publications (17)

  • Drakesmith H, Prentice A. Viral infection and iron metabolism. Nat Rev Microbiol. 2008 Jul;6(7):541-52. doi: 10.1038/nrmicro1930.

    PMID: 18552864RESULT

  • 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: 25076907RESULT

  • 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: 10669330RESULT

  • 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: 22187937RESULT

  • 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: 29619244RESULT

  • 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: 7811060RESULT

  • 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: 11886437RESULT

  • 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: 8554902RESULT

  • 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: 25291189RESULT

  • 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: 16787239RESULT

  • 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: 8665150RESULT

  • 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: 10051178RESULT

  • 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: 8067783RESULT

  • 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: 18369153RESULT

  • 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: 29719970RESULT

  • 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: 1406879RESULT

  • 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.

    PMID: 28583206RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Deferoxamine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic Acids

Study Officials

  • Yadollah Shakiba, MD, PhD

    Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran

    STUDY DIRECTOR

  • Amir Kiani, PhD

    Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alireza Ghaffarieh, MD

CONTACT

+1-608-698-7334alirezaghaffariyeh@hotmail.com

Yadollah Shakiba, MD, PhD

CONTACT

yshakiba@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Yadollah Shakiba, MD, PhD

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 3, 2020

Study Start

April 1, 2020

Primary Completion

September 1, 2020

Study Completion

March 1, 2021

Last Updated

May 4, 2020

Record last verified: 2020-04

Locations

IR(1)