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Application of Desferal to Treat COVID-19

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ClinicalTrials.gov Identifier: NCT04333550
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Yadollah Shakiba, Kermanshah University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Deferoxamine Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Application of Iron Chelator (Desferal) to Reduce the Severity of COVID-19 Manifestations
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Desferal addition to standard treatment Drug: Deferoxamine
Intravenous infusion of Deferoxamine
Experimental: Experimental: standard treatment Drug: Deferoxamine
Intravenous infusion of Deferoxamine


Outcome Measures
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Primary Outcome Measures :
  1. Mortality rate [ Time Frame: up to 20 days ]
    All cause of death


Secondary Outcome Measures :
  1. change in patients clinical manifestation [ Time Frame: up to 20 days ]
    Mild, Moderate or Severe

  2. change in patients PaO2 [ Time Frame: up to 20 days ]
  3. Length of hospitalization [ Time Frame: up to 20 days ]
    days

  4. C-reactive protein [ Time Frame: up to 20 days ]
  5. lymphocyte count [ Time Frame: up to 20 days ]
  6. length of intensive care unit stay [ Time Frame: 1 to 20 days ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical diagnosis of COVID-19 Disease,

Exclusion Criteria:

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333550


Contacts
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Contact: Alireza Ghaffarieh, MD +1-608-698-7334 alirezaghaffariyeh@hotmail.com
Contact: Yadollah Shakiba, MD, PhD yshakiba@gmail.com

Locations
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Iran, Islamic Republic of
Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran Recruiting
Kermanshah, Iran, Islamic Republic of, 083
Contact: Yadollah Shakiba, MD, PhD         
Sponsors and Collaborators
Kermanshah University of Medical Sciences
Investigators
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Study Director: Yadollah Shakiba, MD, PhD Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
Principal Investigator: Amir Kiani, PhD Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
More Information
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Publications of Results:

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Responsible Party: Dr. Yadollah Shakiba, Dr. Yadollah Shakiba, MD, PhD, Kermanshah University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04333550    
Other Study ID Numbers: 1398.1224
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Yadollah Shakiba, Kermanshah University of Medical Sciences:
COVID-19, Deferoxamine
Additional relevant MeSH terms:
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Deferoxamine
Siderophores
Iron Chelating Agents
 Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action