Investigating the effect of Pentoxifylline drug on the clinical progression of covid-19 in patients with acute respiratory failure of moderate severity in the intervention and control groups
Pentoxifylline is effective in reducing the symptoms of respiratory distress in patients with moderate severity and improving oxygen saturation and can be used as an effective drug in Coevid 19.
Design
Data are collected in two groups of intervention and control and will be analyzed by SPSS software.
Clinical trial with control group, with parallel group and single-phase phase 2 blind on 70 patients.
Settings and conduct
The study will be performed interventionally and after obtaining informed consent from patients and pentoxifylline will be given to the intervention group at a dose of 400 mg once a day. Patients who refer to Ayatollah Taleghani Medical Training Center due to positive Covid will participate in the study. To blind a colleague, another doctor will be in charge of assigning patients.
The statistician will also be unaware of the intervention and control group and will conduct the study in two groups A and B.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age whose test results are positive and have a lung T-scan course and their blood oxygen saturation with canola nasal and simple mask is 90% and higher.
Intervention groups
34 patients in each group who wish to participate in the study, 34 patients are in the control group. Matching will be done in terms of receiving RamedSavier and Corton.
Main outcome variables
If pentoxifylline is effective in reducing the symptoms of respiratory distress in patients with moderate severity and improving oxygen saturation, it can be used as an effective drug in covid 19.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210517051326N1
Registration date:2023-04-27, 1402/02/07
Registration timing:retrospective
Last update:2023-04-27, 1402/02/07
Update count:0
Registration date
2023-04-27, 1402/02/07
Registrant information
Name
Sedighe sadat Akhlaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1799
Email address
sediqakhlaghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Pentoxifylline drug on the clinical progression of covid-19 in patients with acute respiratory failure of moderate severity in the intervention and control groups
Public title
Effect of pentoxifillyn on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive test of PCR test COVID-19
ََAge more than 18
SpO2 more than 90%
Exclusion criteria:
Sever COVID-19
Need for treatment with Mechanical ventilation
Need for treatment with high dose corticosteroids
Nausea and vomiting and GIB
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
White and black color cards are used. 35 white cards and 35 black cards are prepared and randomly selected and placed in sealed envelopes from 1 to 70, respectively, and with the arrival of each patient, a special envelope is opened based on the card inside the patient in group A. (White card) or group B (black).
The similarity of the two groups in terms of age, sex, underlying disease and drugs received (patients with moderate lung involvement, symptomatic therapy with painkillers (acetaminophen), antihistamines (diphenhydramine), vitamins C and D) will be statistically evaluated. .
Blinding (investigator's opinion)
Single blinded
Blinding description
To blind a colleague, another doctor will be in charge of assigning patients.
The statistician will also be unaware of the intervention and control group and will conduct the study in two groups A a
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Organizational Committee of Ethics in Biomedical Research
Intervention group: A Participants with usual treatment (curcudone 35 mg daily, vitamin C loan 500 mg daily, heparin 5000 units every 12 hours, dexamethasone 4 mg IV daily), pentoxifylline 400 mg daily every 12 hours they receive.
Category
Treatment - Drugs
2
Description
Control group: Participants in this group receive the usual treatment (curcudone 35 mg daily, vitamin C loan 500 mg daily, heparin 5000 units every 12 hours, dexamethasone 4 mg IV daily).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
taleghani hospital
Full name of responsible person
Sedighe sadat Akhlaghi
Street address
Taleghani Hospital,Shahid Arabi St. Yemen St. Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1335
Fax
+98 21 2243 2581
Email
sediqakhlaghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Sadat Akhlaghi
Street address
Assistant Professor of Education, Ayatollah Taleghani Hospital, first floor, next to the hemodialysis department of Taleghani Hospital, Arab Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1335
Fax
+98 21 2243 2581
Email
sediqakhlaghi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedeqe Sadat Akhlaghi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Assistant Professor of Education, Ayatollah Taleghani Hospital, First floor, Next to the Hemodialysis Department of Taleghani Hospital, Arab Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1335
Fax
+98 21 2243 2581
Email
sediqakhlaghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Sadat Akhlaghi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Assistant Professor of Education, Ayatollah Taleghani Hospital, First floor, next to the Hemodialysis Department of Taleghani Hospital, Arab Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1335
Fax
+98 21 2243 2581
Email
sediqakhlaghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Sadat Akhlaghi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Assistant Professor of Education, Ayatollah Taleghani Hospital, First floor, Next to the Hemodialysis Department of Taleghani Hospital, Arab Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1335
Fax
+98 21 2243 2581
Email
sediqakhlaghi@yahoo.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
Others researchers can access via the co responder email
When the data will become available and for how long
6 months afters publish article of research
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
More research
From where data/document is obtainable
Others researchers can access via the co responder email
What processes are involved for a request to access data/document
Others researchers can access via the co responder email