COVID-19Phase 1/2NCT04333550
Application of Desferal to Treat COVID-19
A Phase 1/2 study testing Deferoxamine in people with COVID-19, run by Kermanshah University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 99 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Deferoxamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Apr 2020to Mar 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of COVID-19 Disease,
Who cannot join
- Previous history of allergy to Deferoxamin, Pregnancy, kidney dysfunction,
Trial locations and contacts
1 site in 1 country.
Yadollah Shakiba, MD, PhD contact
Iran1 site, 1 recruiting
- Recruiting
Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
Kermanshah, 083
Yadollah Shakiba, MD, PhD
About this study
Official title: Application of Iron Chelator (Desferal) to Reduce the Severity of COVID-19 Manifestations
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.
- Conditions
- COVID-19
- Being tested
- Deferoxamine
- Keywords
- COVID-19, Deferoxamine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeferoxamineDrug
Intravenous infusion of Deferoxamine
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Desferal addition to standard treatment | Experimental | Not described Receives: Drug: Deferoxamine |
| Experimental: standard treatment | Experimental | Not described Receives: Drug: Deferoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
All cause of death
Measured: up to 20 days
Secondary outcomes (6)
change in patients clinical manifestation
Mild, Moderate or Severe
Measured: up to 20 days
change in patients PaO2
Measured: up to 20 days
Length of hospitalization
days
Measured: up to 20 days
C-reactive protein
Measured: up to 20 days
lymphocyte count
Measured: up to 20 days
length of intensive care unit stay
Measured: 1 to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kermanshah University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yadollah Shakiba, Kermanshah University of Medical Sciences
- Investigators
- Yadollah Shakiba, MD, PhD, Study director, Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, IranAmir Kiani, PhD, Principal investigator, Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333550
- Sponsor's protocol ID
- 1398.1224
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Drakesmith H, Prentice A. Viral infection and iron metabolism. Nat Rev Microbiol. 2008 Jul;6(7):541-52. doi: 10.1038/nrmicro1930.
PubMed 18552864Nairz 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.
PubMed 25076907Georgiou 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.
PubMed 10669330Vlahakos 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.
PubMed 22187937Wang 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.
PubMed 29619244Cinatl 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.
PubMed 7811060Visseren 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.
PubMed 11886437Sappey 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.
PubMed 8554902Chang 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.
PubMed 25291189Meyer 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.
PubMed 16787239Cinatl 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.
PubMed 8665150Mabeza 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.
PubMed 10051178Weinberg 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.
PubMed 8067783Paradkar 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.
PubMed 18369153Giannakopoulou 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.
PubMed 29719970
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Iron Chelator (Desferal) to Reduce the Severity of COVID-19 Manifestations
- ClinicalTrials.gov ID
- NCT04333550
- Acronym / sponsor ID
- 1398.1224
- Conditions
- COVID-19
- Keywords
- COVID-19, Deferoxamine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kermanshah University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Desferal addition to standard treatment | Experimental | Drug: Deferoxamine |
| Experimental: standard treatment | Experimental | Drug: Deferoxamine |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of COVID-19 Disease,
Key exclusion criteria (1 listed)
- Previous history of allergy to Deferoxamin, Pregnancy, kidney dysfunction,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeferoxamineIntravenous infusion of Deferoxamine | Drug | Experimental: Desferal addition to standard treatment, Experimental: standard treatment |
Primary outcome
Mortality rate
Time frame: up to 20 days
All cause of death
6 secondary outcomes
change in patients clinical manifestation
Time frame: up to 20 days
change in patients PaO2
Time frame: up to 20 days
Length of hospitalization
Time frame: up to 20 days
C-reactive protein
Time frame: up to 20 days
lymphocyte count
Time frame: up to 20 days
length of intensive care unit stay
Time frame: 1 to 20 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Results publication: PubMed 18552864Drakesmith H, Prentice A. Viral infection and iron metabolism. Nat Rev Microbiol. 2008 Jul;6(7):541-52. doi: 10.1038/nrmicro1930.
- Results publication: PubMed 25076907Nairz 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.
- Results publication: PubMed 10669330Georgiou 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.
- Results publication: PubMed 22187937Vlahakos 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.
- Results publication: PubMed 29619244Wang 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.
- Results publication: PubMed 7811060Cinatl 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.
- Results publication: PubMed 11886437Visseren 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.
- Results publication: PubMed 8554902Sappey 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.
- Results publication: PubMed 25291189Chang 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.
- Results publication: PubMed 16787239Meyer 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.
- Results publication: PubMed 8665150Cinatl 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.
- Results publication: PubMed 10051178Mabeza 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yadollah Shakiba, MD, PhD contact
Yadollah Shakiba, MD, PhD study director
Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
Amir Kiani, PhD principal investigator
Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Deferoxamine in people with COVID-19, run by Kermanshah University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alireza Ghaffarieh, MD (+1-608-698-7334, alirezaghaffariyeh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: up to 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333550, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.