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Evaluation of the effects of Pentoxifylline in improving the condition of patients with Covid-19

Protocol summary

Study aim
The aim of this study was to investigate the effects of Pentoxifylline in improving the condition of patients with Covid-19 including saturation of arterial oxygen.
Design
Phase 3 clinical trial, randomized, single blinded with parallel groups on 130 patients
Settings and conduct
Patients referred to Imam Ali Hospital in Alborz, Iran, first performed CT-scan of the chest and then RT-PCR test. Immediately after CT-Scan and Covid-19 clinical diagnosis, patients were divided into intervention and control groups. Patients were monitored for arterial oxygen saturation during hospitalization. The average follow-up time for patients was 10 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria icluded clinical signs of fever (above 38.3 C), dyspnea and cough, and Covid-19 diagnosis based on RT-PCR. Exclusion criteria included diabetes, chronic cardiovascular disease, obesity (with a BMI above 30 kg/m2), cancer, chronic kidney disease, and end-stage kidney disease with hemodialysis.
Intervention groups
Intervention group: Pentoxifylline with a dose of 400 mg, made by Farabi Iran Pharmaceutical Company, was prescribed to patients weighing less than 70 kg every 12 hours and to patients weighing more than 70 kg every 8 hours. This group receives only Pentoxifylline for two days from the hospitalization day. Control group: Vitamin D3 (oral capsule) with a dose of 50,000 units, one capsule at hospitalization day, hydroxychloroquine tablets with a dose of 200 mg every 12 hours for two days from the hospitalization day, serum therapy (2.5 to 3.5 liters) and Nasal Prong was prescribed two to eight liters (based on the patient's dyspnea condition).
Main outcome variables
arterial oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200705048013N1
Registration date: 2020-07-19, 1399/04/29
Registration timing: retrospective

Last update: 2020-07-19, 1399/04/29
Update count: 0
Registration date
2020-07-19, 1399/04/29
Registrant information
Name
Davood Mohammadshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3255 8920
Email address
d.shahi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
2020-02-20, 1398/12/01
Actual recruitment end date
2020-06-19, 1399/03/30
Trial completion date
2020-07-05, 1399/04/15
Scientific title
Evaluation of the effects of Pentoxifylline in improving the condition of patients with Covid-19
Public title
The effect of Pentoxifylline in patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical signs of fever (above 38.3 °C), dyspnea and cough Definite diagnosis of of Covid-19 based on RT-PCR
Exclusion criteria:
Diabetes Chronic cardiovascular disease Obesity (with BMI higher than 30 kg/m2) Cancer Chronic kidney disease End-stage renal disease with hemodialysis
Age
From 30 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 150
Actual sample size reached: 130
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into intervention and control groups based on the last digit of the National ID number based on even and odd numbers, respectively. The zero was also considered even.
Blinding (investigator's opinion)
Single blinded
Blinding description
The control and intervention group entered the statistical analysis software in coded form and only the researcher and clinical caregiver will be aware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Faculty of medicine, Hassan Abad Ave.
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2020-05-30, 1399/03/10
Ethics committee reference number
IR.ABZUMS.REC.1399.102

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Oxygen saturation of arterial blood
Timepoint
Before intervention, daily after intervention
Method of measurement
Pulse-oximeter monitoring

Secondary outcomes

1

Description
Mortality
Timepoint
7, 14, 21 and 28 days after intervention
Method of measurement
Clinical examination by physician and confirmation of death

2

Description
Refer to the intensive care unit
Timepoint
7, 14, 21 and 28 days after intervention
Method of measurement
Clinical Frailty Scale

Intervention groups

1

Description
Intervention group: Pentoxifylline with a dose of 400 mg, made by Farabi Pharmaceutical Company, Iran, was prescribed to patients weighing less than 70 kg every 12 hours and to patients weighing more than 70 kg every 8 hours. This group receives only Pentoxifylline for two days from the hospitalization day.
Category
Treatment - Drugs

2

Description
Control group: Vitamin D3 (oral capsule) with a dose of 50,000 units, one capsule at hospitalization day, hydroxychloroquine tablets with a dose of 200 mg every 12 hours for two days from the hospitalization day, serum therapy (2.5 to 3.5 liters) and Nasal Prong two to eight liters (depending on the patient's dyspnea condition) were prescribed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam-Ali hospital
Full name of responsible person
Davood Mohammadshahi
Street address
In front of the Daryani garden, Chalous Ave., Taleghani BLV.
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3256 2358
Email
d.shahi@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mohammad Nouri-Sepehr
Street address
Deputy of Research and Technology, Saffarian Alley, 45 meters from Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Oroumia University of Medical Sciences
Full name of responsible person
Sajjad Pourasghary
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Library Unit, ImamReza Hospital, Daneshghah Street, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3667 0577
Email
pourasghary.s@umsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Davood Mohammadshahi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Ali hospital, In front of the Daryani garden, Chalous Ave., Taleghani BLV.
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3255 8920
Fax
Email
d.shahi@abzums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sajjad Pourasghary
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Library Unit, ImamReza Hospital, Daneshghah Street, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3667 0577
Email
pourasghary.s@umsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.
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