Evaluation of the efficacy and safety of oral pentoxifylline in treatment and recovery of patients with COVID-19 admitted in Rasoul Akram and firoozgar hospitals treated with routine protocols, A randomized controlled clinical trial
Evaluation of the efficacy and safety of oral pentoxifylline in treatment and recovery of patients with COVID-19 admitted in Rasoul Akram and firoozgar hospitals who are under treatment with routine protocols, A randomized controlled clinical trial
Design
Randomization will only be done at the center level, which will be done in a simple random way (coin toss). Then all patients in the selected center will receive standard treatment in addition to pentoxifylline treatment in control group in another center. In this plan, patients and evaluators are not blind.
Settings and conduct
Hazrat Rasool akram and Firoozgar hospitals, covid-19 admission wards for conduct a randomized clinical trial
Participants/Inclusion and exclusion criteria
Inclusion and exclusion criteria: aged 18-90 years, moderate to severe admitted stable COVID patients, not any bleeding disorders, no heart attack and stroke, no ocular and cerebral hemorrhage, not pregnant or breastfeeding, intolerance or allergy to PTX or xanthines, no gastric ulcer, no porphyria, no significant impairment of kidney or liver or heart function, no history of major surgery (last 2 weeks), no cancer, no use of any therapeutic blood thinners, pressure drop below (10) or unstable vital signs
Intervention groups
Treatment in both control and intervention groups will be based on the use of common treatment protocols in patients with covid-19. In the intervention group,oral PTX (400 milligram TDS for up to 2 weeks) will be added to the routine treatment (hydroxychlroquine (400 milligram stat then 200 miligram BID)+sofosbuvir/daclatasvir (400/60 milligram)), for 7-10 days.
Main outcome variables
fever/cough/dyspenia/o2 level/duration of administration/laboratory parameters/ radiologicchanges/ICU admission/death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170809035597N2
Registration date:2020-11-16, 1399/08/26
Registration timing:registered_while_recruiting
Last update:2020-11-16, 1399/08/26
Update count:2
Registration date
2020-11-16, 1399/08/26
Registrant information
Name
Azadeh Goodarzi
Name of organization / entity
Iran University of Medical Sciences (IUMS), Rasool Akram hospital, Department of Dermatology
Country
Iran (Islamic Republic of)
Phone
+98 66502040
Email address
goodarzi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-17, 1399/05/27
Expected recruitment end date
2020-11-17, 1399/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of oral pentoxifylline in treatment and recovery of patients with COVID-19 admitted in Rasoul Akram and firoozgar hospitals treated with routine protocols, A randomized controlled clinical trial
Public title
Efficacy and safety of pentoxifylline in treatment and recovery of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Admitted patients with COVID-19
Moderate to severe disease
Stable patients
Patients should not have bleeding disorders
Patients do not have a history of heart attack and stroke
Patients without history of ocular or cerebral hemorrhage
No pregnancy or breastfeeding
Patients without history of intolerance to PTX or other xanthines such as caffeine, theophylline and tobromine
Patients without gastric ulcers
Patient without history of porphyria
Patients with no prominent renal or hepatic or cardiac dysfunction
Patients without history of major surgery in the past 2 weeks
Patients without history of cancer
Patients without need to use any therapeutic blood thinners, including aspirin and warfarin
Exclusion criteria:
Allergy to any of the drugs studied, including pentoxifylline
Occurrence of any bleeding during the study (in the stomach, brain, eyes, ...)
Drug intolerance or the occurrence of any severe side effects during treatment, such as gastrointestinal intolerance, does not respond to pre-determined measures of anti-acids... or the occurrence of skin drug reactions to the received treatment protocol and ...
Being pregnant during the study
Occurrence of heart attack and stroke during the study
Drop in pressure below 10 mm Hg or instability of the patient's vital signs
Require intubation during study or hospitalization in the ICU
Increase in the severity of COVID-19 disease during the study so that the need for hospitalization in the ICU or the need to change the treatment protocol
The use of a therapeutic drug other than the standard drug in this study
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will only be done at the center level, which will be done in a simple random way (coin toss).
Since the samples required for the study will be collected from two centers, so one center will be the center of the intervention randomly and one center will be the center of control randomly and in each center the basic treatment regimen will be prescribed on a regular basis (HydroxyChloroquine + Sofosbuvir) and the intervention center will receive pentoxifylline in addition to the mentioned diet, so the blinding of patients is not seen in the plan, and on the other hand each center will have its own special and trained evaluator, and therefore there is no blinding of evaluator and only the data analyst who does not know the type of drug used in the centers is blind.
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 Iran University of medical scinces
Time to improve symptoms such as cough, shortness of breath and lethargy
Timepoint
At the beginning of the hospitalization/ two weeks after treatment
Method of measurement
Clinical evaluation
2
Description
O2 saturation
Timepoint
At the beginning of the hospitalization/ two weeks after treatment
Method of measurement
Clinical evaluation and pulse oximetery
3
Description
Re-hospitalization after discharge
Timepoint
At the beginning of the hospitalization/ two weeks after treatment
Method of measurement
Clinical evaluation
4
Description
Duration of hospitalization
Timepoint
After discharge
Method of measurement
Days
5
Description
Evaluation of laboratory parameters as a series of factors: PCR and LDH, CBC, ESR, CRP
Timepoint
At the beginning of the hospitalization/ during hospitalization/ at discharge time
Method of measurement
Lab data analysis
6
Description
Check for changes in anti-inflammatory parameters (TNF-ALPHA and IL-6 if measuring kits are available)
Timepoint
At the beginning of the hospitalization/ at discharge time
Method of measurement
Lab data analysis
7
Description
Investigation of radiological changes at the beginning of hospitalization and during hospitalization if possible
Timepoint
At the beginning of the hospitalization/ during hospitalization
Method of measurement
Radiographic changes
8
Description
Need to ICU admission
Timepoint
During hospitalization
Method of measurement
Clinical evaluation
9
Description
Recovery or death
Timepoint
During hospitalization or in follow-up period
Method of measurement
Observation
Secondary outcomes
1
Description
Side effects
Timepoint
Time to start the intervention/ during hospitalization, two weeks after interventions
Method of measurement
Clinical, laboratory evaluation
2
Description
Need change initial treatment or add new drug to the regimen
Timepoint
During hospitalization
Method of measurement
Clinical assessment
Intervention groups
1
Description
Intervention group: In the intervention group,oral PTX (400 milligram TDS for up to 2 weeks) will be added to the routine treatment (hydroxychlroquine (400 milligram stat then 200 miligram BID)+sofosbuvir/daclatasvir (400/60 milligram)), for 7-10 days.
Category
Treatment - Drugs
2
Description
Control group: In the control group, routine treatment as (hydroxychlroquine (400 milligram stat then 200 miligram BID)+sofosbuvir/daclatasvir (400/60 milligram)), for 7-10 days, will be administered.
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
Evaluation of the efficacy and safety of oral pentoxifylline in treatment and recovery of patients with COVID-19 admitted
in Rasoul Akram and firoozgar Hospitals who are under treatment with routine protocols, A randomized controlled clinical trial
When the data will become available and for how long
The data will be available after 6-7 month starting the study
To whom data/document is available
For all people and physician may have concern about COVID-19 and its management
Under which criteria data/document could be used
In patients with COVID-19 as a probable adjuvant therapy in the setting of no contraindication for this drug
From where data/document is obtainable
Via related published article
What processes are involved for a request to access data/document