Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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Hazrat Rasool akram and Firoozgar hospitals, covid-19 admission wards for conduct a randomized clinical trial
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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fever/cough/dyspenia/o2 level/duration of administration/laboratory parameters/ radiologicchanges/ICU admission/death
General information
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Reason for update
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Changing the final sample size at the end of the study from 86 to 150 patients
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170809035597N2
Registration date:
2020-11-16, 1399/08/26
Registration timing:
registered_while_recruiting
Last update:
2022-02-14, 1400/11/25
Update count:
2
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Registration date
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2020-11-16, 1399/08/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-08-17, 1399/05/27
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Expected recruitment end date
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2020-11-17, 1399/08/27
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Efficacy and safety of pentoxifylline in treatment and recovery of patients with COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 90 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
150
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-08-25, 1399/06/04
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Ethics committee reference number
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IR.IUMS.REC.1399.458
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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Time to improve symptoms such as cough, shortness of breath and lethargy
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Timepoint
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At the beginning of the hospitalization/ two weeks after treatment
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Method of measurement
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Clinical evaluation
2
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Description
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O2 saturation
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Timepoint
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At the beginning of the hospitalization/ two weeks after treatment
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Method of measurement
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Clinical evaluation and pulse oximetery
3
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Description
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Re-hospitalization after discharge
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Timepoint
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At the beginning of the hospitalization/ two weeks after treatment
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Method of measurement
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Clinical evaluation
4
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Description
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Duration of hospitalization
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Timepoint
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After discharge
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Method of measurement
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Days
5
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Description
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Evaluation of laboratory parameters as a series of factors: PCR and LDH, CBC, ESR, CRP
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Timepoint
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At the beginning of the hospitalization/ during hospitalization/ at discharge time
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Method of measurement
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Lab data analysis
6
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Description
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Check for changes in anti-inflammatory parameters (TNF-ALPHA and IL-6 if measuring kits are available)
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Timepoint
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At the beginning of the hospitalization/ at discharge time
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Method of measurement
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Lab data analysis
7
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Description
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Investigation of radiological changes at the beginning of hospitalization and during hospitalization if possible
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Timepoint
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At the beginning of the hospitalization/ during hospitalization
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Method of measurement
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Radiographic changes
8
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Description
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Need to ICU admission
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Timepoint
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During hospitalization
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Method of measurement
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Clinical evaluation
9
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Description
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Recovery or death
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Timepoint
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During hospitalization or in follow-up period
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Method of measurement
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Observation
Secondary outcomes
1
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Description
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Side effects
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Timepoint
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Time to start the intervention/ during hospitalization, two weeks after interventions
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Method of measurement
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Clinical, laboratory evaluation
2
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Description
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Need change initial treatment or add new drug to the regimen
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Timepoint
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During hospitalization
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Method of measurement
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Clinical assessment
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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
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When the data will become available and for how long
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The data will be available after 6-7 month starting the study
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To whom data/document is available
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For all people and physician may have concern about COVID-19 and its management
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Under which criteria data/document could be used
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In patients with COVID-19 as a probable adjuvant therapy in the setting of no contraindication for this drug
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From where data/document is obtainable
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Via related published article
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What processes are involved for a request to access data/document
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Purchase published article
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Comments
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