Protocol summary

Study aim
the effectiveness of pentoxifylline compared to dexamethasone in diabetic patients with covid-19
Design
The double-blind, randomized, controlled trial study conducted on 50 diabetic patients with COVID-19. Randomization will be performed using a table of random numbers. Patients will be randomly assigned to either the pentoxifylline/dexamethasone group or the dexamethasone-only group after obtaining written informed consent.
Settings and conduct
Patients diagnosed with COVID-19 who are hospitalized in two educational hospitals in Yazd (Shahid Rahnamoon and Shahid Sadoughi Hospitals) will be included in the study, provided that they have diabetes.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 70 years with a diagnosis of COVID-19 within the last 24 to 48 hours, and candidates for hospitalization (o2sat <93%, RR> 24, or Pao2/Fio2 <300) are enrolled in the study. Patients undergoing treatment with Kaletra, patients with hemodynamic instability, drug intolerance, a history of Crohn's, chronic diarrhea, neuromuscular diseases, GFR less than 30 ml/min, a history of cirrhosis, hepatitis, or severe liver disease, patients with cancer, and pregnant or lactating patients will be excluded from the study.
Intervention groups
patients are treated with a dosage of 400 mg three times a day, along with intravenous administration of dexamethasone at a dose of 4 mg every 12 hours. In the control group, patients only receive intravenous dexamethasone at a dose of 4 mg every 12 hours. Treatment continues for seven days.
Main outcome variables
The improvement of the general condition of the patients, the levels of inflammatory markers and the level of involvement in the HRCT before the admission of the patients, any possible drug complications, as well as the need for hospitalization in the intensive care unit and the need for intubation, as well as the mortality rate will be recorded.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230523058271N1
Registration date: 2023-10-08, 1402/07/16
Registration timing: retrospective

Last update: 2023-10-08, 1402/07/16
Update count: 0
Registration date
2023-10-08, 1402/07/16
Registrant information
Name
zahra falahati marvast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3837 4596
Email address
zs.falahati1988@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-12, 1401/10/22
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
2023-01-15, 1401/10/25
Actual recruitment end date
2023-05-20, 1402/02/30
Trial completion date
2023-05-20, 1402/02/30
Scientific title
Evaluation of the efficacy of Pentoxiphyllin in hospitalized diabetic patients with covid19
Public title
Evaluation of the efficacy of Pentoxiphyllin in hospitalized diabetic patients with covid19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of covid in the last 24 to 48 hours Candidate for hospitalization (o2sat<93% or RR>24 or Pao2/Fio2<300) Covid-19 patients who are candidates for hospitalization with indications for hospitalization according to the country's guidelines, who had pulmonary infiltration in CT scan Outpatients with pulmonary infiltration on CT scan Age 18 to 70 years
Exclusion criteria:
Patients who were treated with Coltera (lupinavir/ritonavir). Patients with shock or hemodynamic instability Drug intolerance Patients with a history of Crohn's or ulcerative colitis, diarrhea or chronic malabsorption Neuromuscular diseases GFR less than 30 ml/min History of cirrhosis, hepatitis and severe liver diseases Patients receiving chemotherapy for cancer Pregnancy and breastfeeding
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Actual sample size reached: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria are divided into two groups by a simple randomization method and based on the table of random numbers prepared by the statistics consultant whom out of the study, and the grouping of each person is in a sealed envelope at the disposal of the relevant doctor and the nursing team. will be placed
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, the researcher and the statistical analyst will not know about the grouping. In this way, only the doctor who prescribed the patient's orders, the nursing team and the patient knew about the medicine received, and the researcher who was responsible for collecting the information and results of the patients would not know about the grouping, and the statistical researcher would also know that each of It will not be known what drugs the groups received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Shahid Sadoughi University of Medical Sciences, Shohday gomnam Boulevard, Alam Square, Yazd, Iran
City
yazd
Province
Yazd
Postal code
8916978477
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
Post-COVID
ICD-10 code description
U09

Primary outcomes

1

Description
recovery
Timepoint
It is evaluated during the first 72 hours after hospitalization and the start of the intervention.
Method of measurement
It is evaluated in the form of arterial blood oxygen level of at least 93%, cessation of fever for 72 hours and improvement of the general condition through a questionnaire.

2

Description
IL-6
Timepoint
At the start of treatment and after one week from the start of treatment
Method of measurement
kit

3

Description
CRP
Timepoint
At the start of treatment and after one week from the start of treatment
Method of measurement
kit

4

Description
ESR
Timepoint
At the start of treatment and after one week from the start of treatment
Method of measurement
KIT

5

Description
ferritin
Timepoint
At the start of treatment and after one week from the start of treatment
Method of measurement
kit

6

Description
Involvement in HRCT
Timepoint
At the start of treatment and after one week from the start of treatment
Method of measurement
Using CT SCAN observation and evaluation by a lung specialist

7

Description
Hospitalization in ICU
Timepoint
During the course of treatment
Method of measurement
CHECKLIST

8

Description
death
Timepoint
During the course of treatment
Method of measurement
CHECKLIST

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They are treated with pentoxifylline 400 mg three times a day along with intravenous dexamethasone 4 mg every 12 hours.
Category
Treatment - Drugs

2

Description
Control group: They are treated with intravenous dexamethasone 4 mg every 12 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadouqi Hospital
Full name of responsible person
Zahra Falahati marvast
Street address
Shahid Sadouqi Hospital, Ebne sina blv, yazd. iran
City
YAZD
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
ssu.ac.ir@email.com

2

Recruitment center
Name of recruitment center
Shahid Rahnamun Hospital
Full name of responsible person
Zahra Falahati marvast
Street address
Shahid Rahnamun Hospital, emam street, yazd, iran
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3837 4596
Email
Rahnemun@email.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
Shahid Sadoughi University of Medical Sciences, Shohday gomnam Boulevard, Alam Square, Yazd, Iran
City
yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3628 8114
Email
abargouei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Vice President of Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Zahra Falahati marvast
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shohday gomnam Boulevard, Alam Square, Yazd, Iran
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3837 4597
Email
zs.falahati1988@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Falahati marvast
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shohday gomnam Boulevard, Alam Square, Yazd, Iran
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3837 4596
Email
zs.falahati1988@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Falahati marvast
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shohday gomnam Boulevard, Alam Square, Yazd, Iran
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3837 4596
Email
zs.falahati1988@gmail.com

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
Yes - There is 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
Only a part of the data, such as the information related to the main outcome or the like, can be shared.
When the data will become available and for how long
One year after the time of publication
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data will be available only to researchers working in academic and scientific institutions
From where data/document is obtainable
The data will only be available to researchers working in academic and scientific institutions through the following email address.
What processes are involved for a request to access data/document
Only the data related to the main results of the study can be presented to the mentioned people after mentioning the valid reason.
Comments
Loading...