Back to resultsApplication of Desferal to Treat COVID-19
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Deferoxamine
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Deferoxamine
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of COVID-19 Disease,
Exclusion Criteria:
Previous history of allergy to Deferoxamin, Pregnancy, kidney dysfunction,
Sites / Locations
- Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, IranRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental: Desferal addition to standard treatment
Experimental: standard treatment
Arm Description
Outcomes
Primary Outcome Measures
Mortality rate
All cause of death
Secondary Outcome Measures
change in patients clinical manifestation
Mild, Moderate or Severe
change in patients PaO2
Length of hospitalization
days
C-reactive protein
lymphocyte count
length of intensive care unit stay
Full Information
NCT ID
NCT04333550
First Posted
April 1, 2020
Last Updated
April 30, 2020
Sponsor
Kermanshah University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04333550
Brief Title
Application of Desferal to Treat COVID-19
Official Title
Application of Iron Chelator (Desferal) to Reduce the Severity of COVID-19 Manifestations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kermanshah University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Deferoxamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Desferal addition to standard treatment
Arm Type
Experimental
Arm Title
Experimental: standard treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Deferoxamine
Intervention Description
Intravenous infusion of Deferoxamine
Primary Outcome Measure Information:
Title
Mortality rate
Description
All cause of death
Time Frame
up to 20 days
Secondary Outcome Measure Information:
Title
change in patients clinical manifestation
Description
Mild, Moderate or Severe
Time Frame
up to 20 days
Title
change in patients PaO2
Time Frame
up to 20 days
Title
Length of hospitalization
Description
days
Time Frame
up to 20 days
Title
C-reactive protein
Time Frame
up to 20 days
Title
lymphocyte count
Time Frame
up to 20 days
Title
length of intensive care unit stay
Time Frame
1 to 20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of COVID-19 Disease,
Exclusion Criteria:
Previous history of allergy to Deferoxamin, Pregnancy, kidney dysfunction,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alireza Ghaffarieh, MD
Phone
+1-608-698-7334
Email
alirezaghaffariyeh@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yadollah Shakiba, MD, PhD
Email
yshakiba@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yadollah Shakiba, MD, PhD
Organizational Affiliation
Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amir Kiani, PhD
Organizational Affiliation
Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
City
Kermanshah
ZIP/Postal Code
083
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yadollah Shakiba, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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18552864
Citation
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Application of Desferal to Treat COVID-19
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