Protocol summary

Study aim
Determining the effectiveness of pentoxifylline in diabetic patients with covid-19 hospitalized in Shahid Rahmonun Hospital, Yazd.
Design
A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 100 patients. The rand function of Excel software was used for randomization.
Settings and conduct
At least 24 inpatient diabetic patients with COVID-19 over the age of 18 and receiving either pentoxifylline (400 mg three times a day) or dexamethasone (4 mg every 12 hours) will be studied. Improvement of patients is defined as arterial blood oxygen level of at least 93%, cessation of fever for 72 hours, and improvement of the general condition of patients. The levels of inflammatory markers, including serum interleukin 6, CRP, ESR, and ferritin, were checked in both groups at the beginning of the treatment and after one week from the start of the treatment. The person monitoring the patients will not be aware of the grouping done.
Participants/Inclusion and exclusion criteria
Patients: Having type 1 or 2 diabetes Infected with covid-19 Hospitalization in the non-specialized departments of Shahid Rahnamon Hospital, Yazd Age above 18 years
Intervention groups
In the pentoxifylline group, patients are treated with this drug at the rate of 400 mg three times a day, and in the opposite group, patients are only treated with intravenous administration of dexamethasone 4 mg every 12 hours.
Main outcome variables
Levels of inflammatory markers including serum interleukin 6, CRP, ESR, and ferritin

General information

Reason for update
Acronym
پنتوکسی فیلین در بیماران دیابتی مبتلا به کووید 19
IRCT registration information
IRCT registration number: IRCT20190810044500N29
Registration date: 2024-10-12, 1403/07/21
Registration timing: retrospective

Last update: 2024-10-12, 1403/07/21
Update count: 0
Registration date
2024-10-12, 1403/07/21
Registrant information
Name
Fatemeh Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
f.saghafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-11, 1401/10/21
Expected recruitment end date
2023-04-09, 1402/01/20
Actual recruitment start date
2023-01-13, 1401/10/23
Actual recruitment end date
2023-04-19, 1402/01/30
Trial completion date
2023-04-19, 1402/01/30
Scientific title
Investigating the effectiveness of pentoxifylline in diabetic patients with covid-19 : a clinical trial
Public title
Evaluation of the efficacy of Pentoxiphyllin in hospitalized diabetic patients with Covid-19
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patient with covid-19 hospitalized in non-specialized departments of teaching hospitals of Yazd University of Medical Sciences
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 40
Actual sample size reached: 47
Randomization (investigator's opinion)
Randomized
Randomization description
Each of the interventions was named with letters A and B, and the rand function of Excel software was used for randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome evaluator is blindfolded about the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Ethics of Medical Sciences, Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences,Shohaday gomnam Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2023-01-11, 1401/10/21
Ethics committee reference number
IR.SSU.MEDICINE.REC.1401.198

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
IL6 marker level in serum
Timepoint
Weekly
Method of measurement
Blood test

2

Description
ESR marker level in serum
Timepoint
Weekly
Method of measurement
Blood test

3

Description
CRP marker level in serum
Timepoint
Weekly
Method of measurement
Blood test

4

Description
Ferritin marker level in serum
Timepoint
weekly
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the pentoxifylline group, patients are treated with 400 mg three times a day with pentoxifylline.
Category
Treatment - Drugs

2

Description
Control group: Patients are only treated with intravenous administration of dexamethasone 4 mg every 12 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd teaching hospitals
Full name of responsible person
Fatemeh Sahafi
Street address
Shahid Ghandi Blvd
City
Yazd
Province
Yazd
Postal code
8915857958
Phone
+98 35 3822 4000
Email
saghafi.fa@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
dr amin salehi
Street address
The central building of Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
9856783459
Phone
+98 35 3146 2056
Email
abargouei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
20
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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh saghafi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
critical care
Street address
Shahid Sadoughi University of Medical Sciences, Shohada gomnam Blvd
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3419
Email
sahafi.fa@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
The central building of Yazd University of Medical Sciences, Bahonar Square.
City
Yazd
Province
Yazd
Postal code
9856783459
Phone
+98 35 3146 2056
Email
abargouei@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Saghafi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
critical care
Street address
Shahid Sadoughi University of Medical Sciences, Shohada gomnam Blvd
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3419
Email
saghafi.fa@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
After the analysis, the data are made available to others in the form of a scientific article
When the data will become available and for how long
Spring to summer 2024
To whom data/document is available
unlimited
Under which criteria data/document could be used
unlimited
From where data/document is obtainable
dr fatemeh saghafi saghafi.fa@gail.com
What processes are involved for a request to access data/document
saghafi.fa@gail.com
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