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Evaluation of the effect of pentoxifylline in reducing the complications of Covid _19

Protocol summary

Study aim
Evaluation of the effect of pentoxifylline in reducing the complications of Covid _19
Design
Randomized, non-blind, clinical trail with parallel intervention and control group, with 100 Covid 19 patients.
Settings and conduct
This study was done on 100 Covid_ 19 patients in Sina hospital of Tabriz University of Medical Sciences. Patients will receive pantoxifylline 400 mg tablet thrice daily with meal.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: PCR Positive from nasopharyngeal specimen for covid 19 or evidence indicating Covid 19 disease,Moderate to mild symptoms,Less than 7 days after the onset of symptoms Ability to swallow,Age between 18 and 75 and Exclusion criteria are:Shock or failure of several organs, Chronic liver disease,Chronic kidney disease,Pregnancy and lactation,Participation in other clinical studies and Concomitant use of drugs that interact severely with pentoxifylline.
Intervention groups
This randomized, non blind clinical study will be performed on 100 selected patients according to the inclusion and exclusion criteria. Intervention group will receive 400 mg pentoxifylline tablets 3 times a day for 1 month with the standard diet of the Ministry of Health. The condition of patients will be evaluated daily with laboratory and clinical parameters and finally recorded in predesignated checklists. The control group will receive only the standard regimen of the Ministry of Health for 1 month.
Main outcome variables
ُSerum Lactate Dehydrogenase (LDH) level , Serum C_reactive protein (CRP)level ,Percentage of Oxygen saturation in arterial blood(SPO2), prothrombin time (PT) and Partial Thromboplastin Time (PTT) ,Serum Procalcitonin level ,Serum Ferritin and D_dimer level and Serum level Brain natriuretic peptide (NT_ProBNP).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170609034406N8
Registration date: 2021-08-26, 1400/06/04
Registration timing: prospective

Last update: 2021-08-26, 1400/06/04
Update count: 0
Registration date
2021-08-26, 1400/06/04
Registrant information
Name
Afshin Gharekhani
Name of organization / entity
Faculty of Pharmacy/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1315
Email address
gharekhania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of pentoxifylline in reducing the complications of Covid _19
Public title
Investigation of the effect of pentoxifylline on Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive PCR test for nasopharyngeal sample or certain evidence indicating Covid-19 disease Moderate to mild symptoms onset of symptoms within 7 days Ability to swallow Age between 18 and 75
Exclusion criteria:
Shock state or multi-organ failure Chronic liver disease Chronic kidney disease Pregnancy and lactation Participation in other clinical studies Receiving drugs with severe interaction with pentoxifylline
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Permuted Block Randomization method will be used for entering patients into control and treatment groups. There will exist 25 blocks with equal number of patients from each group in this study. Random numbers will be generated by using the Microsoft Excel Spreadsheet Software to randomize blocks and patients allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice-Chancellor, Third floor, No 2 central building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5766414766
Approval date
2021-02-14, 1399/11/26
Ethics committee reference number
IR.TBZMED.REC.1399.1045

Health conditions studied

1

Description of health condition studied
COVID _19
ICD-10 code
U10.9
ICD-10 code description
Multisystem inflammatory syndrome associated with COVID_19

Primary outcomes

1

Description
Serum Procalcitonin level
Timepoint
At the beginning and end of the study
Method of measurement
Procalcitonin kit

2

Description
Serum Ferritin level
Timepoint
At the beginning and end of the study
Method of measurement
Ferritin kit

3

Description
Serum NT_ProBNP level ( Brain natriuretic peptide )
Timepoint
At the beginning and end of the study
Method of measurement
Nt_ProBNP ELISA Kit

4

Description
Serum D_dimer level
Timepoint
At the beginning and end of the study.
Method of measurement
D_dimer ELISA kit

5

Description
ُُSerum LDH (Lactate Dehydrogenase) level
Timepoint
At the beginning and end of the study
Method of measurement
DGKC Kit

6

Description
Partial Thromboplastin Time ( PTT) and prothrombin Time (PT)
Timepoint
At the beginning and end of the study
Method of measurement
PTT and PT Kit

7

Description
Saturation of Peripheral Oxygen in arterial blood ( SPO2 )
Timepoint
At the beginning and end of the study.
Method of measurement
Arterial Blood Gas (ABG Test)

8

Description
Serum C_ reactive protein (CRP) level
Timepoint
At the beginning and end of the study
Method of measurement
CRP ELISA Kit

Secondary outcomes

1

Description
Reducing the length of hospital stay of patients
Timepoint
At the end of study
Method of measurement
Comparing the number of hospitalization days between the intervention group and control group

2

Description
Improving the quality of lung lesions
Timepoint
At the beginning and end of the study.
Method of measurement
CT_Scan of lungs

3

Description
Change in the sense of smell
Timepoint
At the beginning and end of the study.
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group (Pentoxifylline recipient + standard care): 100 patients with COVID-19 diagnosis will be included in the study according to the inclusion and exclusion criteria and will receive 400mg pentoxifylline tablet (produced by Amin pharmaceutical company in Iran) three times daily for 1 month along with the standard care of the Ministry of Health protocol.
Category
Treatment - Drugs

2

Description
Control group: In this clinical study, the control group will receive only the standard care of the Ministry of Health protocol for COVID-19 patients for 1 month.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital of Tabriz University of Medical Sciences
Full name of responsible person
Dr Afshin Gharekhani
Street address
No 2 central building, Tabriz University of Medical sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 2250
Fax
Email
gharekhania@tbzmed.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Afshin Gharekhani
Street address
No 2 central building, Tabriz University of Medical sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5766414766
Phone
+98 41 3337 2250
Email
gharekhania@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Afshin Gharekani
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 2 central building, Tabriz University of Medical sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 2250
Email
gharekhania@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Afshin Gharekani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 2 central building, Tabriz University of Medical sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5766414766
Phone
+98 41 3337 2250
Email
gharekhania@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Atena Hatami Fard
Position
Pharmacy student at Tabriz University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Medical Pharmacy
Street address
No 2 central building, Tabriz University of Medical sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 2250
Email
a.hatamifardddd@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic data and main outcomes will be shared.
When the data will become available and for how long
Data files will become available 6 months after publication.
To whom data/document is available
It will be only available for people working in academic institutions.
Under which criteria data/document could be used
All of the data can be freely used if the citation is appropriately considered .
From where data/document is obtainable
The applicants will be referred to research Vice-chancellor .
What processes are involved for a request to access data/document
All of the requested data should be mentioned in a application letter which will be sent to the Research Vice-chancellor of Tabriz University of Medical Sciences.
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