To determine the effect of Deferiprone on the severity of symptoms and mortality of patients with covid 19
Design
This trial (Phase 3) is performed on 80 patients using a parallel design (40 patients in each group):
Intervention group: In addition to the main drugs recommended by the National Committee for Coronavirus, the group will receive the oral drug Deferiprone as an adjutant treatment.
Control group: The group that will receive only the main drugs recommended by the National Committee for Coronavirus.
The randomization method is based on the formation of Permuted Blocked randomization (each block will consists 4 patients).
Settings and conduct
The study is being conducted at Tohid Hospital in Sanandaj (the provincial treatment center for patients with Qovid 19). Patients, physicians, and nurses who evaluate the outcomes will be blind to the groups studied.
Participants/Inclusion and exclusion criteria
Patients with covid 19 with 18 to 80 years of age will enter to the study.
Patients who had a history of liver or kidney disease, as well as patients with anemia and also patients who have gastroenteritis will be excluded from this trial.
Intervention groups
Deferiprone
Main outcome variables
Improving the symptoms of Covid 19; duration of hospital stay; SPO2 to FiO2 ratio; duration required for RT-PCR test to be negative; mortality; adverse side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180114038350N3
Registration date:2020-05-01, 1399/02/12
Registration timing:prospective
Last update:2020-05-01, 1399/02/12
Update count:0
Registration date
2020-05-01, 1399/02/12
Registrant information
Name
Khaled Rahmani
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3312 5880
Email address
khaledrahmani111@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Deferiprone on the improvement of symptoms of Coronavirus 2019 (COVID 19)
Public title
Effect of Deferiprone on the improvement of symptoms of Coronavirus 2019 (COVID 19)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Covid 19 patients without needing ventilator
Age between 18 to 80
Exclusion criteria:
Patients with anemia
Patients with gastroenteritis
Patients who had history of liver diseases
Patients who had history of renal diseases
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
We will use permuted block randomization (each block consists 4 patients) method to allocate the patients into two study groups (control and intervention)
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants, physicians and nurses who evaluate the outcomes will be blind to the intervention and studied groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences , Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2020-04-20, 1399/02/01
Ethics committee reference number
IR.MUK.REC.1399.012
Health conditions studied
1
Description of health condition studied
Patients with Covid 19
ICD-10 code
U07.01
ICD-10 code description
Covid 19
Primary outcomes
1
Description
Improvement in disease symptoms (Fever and breathing)
Timepoint
This primary outcome is measured for patients before and during 5 days after treatment initiation
Method of measurement
Fever is calculated using mercury thermometers and respiration is calculated using the number of breaths per minute.
Secondary outcomes
1
Description
Duration of hospital stay
Timepoint
Based on the number of days a person is hospitalized
Method of measurement
Medical records
2
Description
Improvement in SPO2 to FiO2 ratio
Timepoint
Percent of SPO2
Method of measurement
Based on Oximeter pulse
3
Description
Death
Timepoint
Number of death in each group
Method of measurement
Medical Records
Intervention groups
1
Description
Intervention group: Oral Deferiprone is added to drugs used to treat Covid 19 (approved by the National Committee).
Category
Treatment - Drugs
2
Description
Control group: Patients receive only the drugs used to treat Quaid 19 (approved by the National Committee).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Hospital, a teaching hospital in Sanandaj
Full name of responsible person
Karim Naseri
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
bihoshi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Kurdistan University of Medical Sciences, Sanandaj, Pasdaran Blvd,
City
Sanandaj
Province
Kurdistan
Postal code
6616797161
Phone
+98 87 3366 4653
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Khaled Rahmani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Kurdistan University of Medical Sciences, Sanandaj, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3366 4673
Email
khaledrahmani111@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Karim Naseri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kurdistan University of Medical Sciences, Sanandaj, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3366 4673
Email
bihoshi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Khaled Rahmani
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Kurdistan University of Medical Sciences, Sanandaj, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3366 4673
Email
khaledrahmani111@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
In case of publisher journal request, data would be sent to the journal.
When the data will become available and for how long
During the publication of paper and 6 months after publish
To whom data/document is available
Editor of the journal that publish the paper and academic researchers with permission of correspondence author
Under which criteria data/document could be used
Data can only used to meta analysis with permission of correspondence author
From where data/document is obtainable
The correspondence author of the study
What processes are involved for a request to access data/document