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IRCT20170809035597N2 IRCT 2020-11-16 Iran University of Medical Sciences Efficacy and safety of pentoxifylline in treatment and recovery of patients with COVID-19 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 2020-08-17 anticipated 150 Complete https://irct.ir/trial/51927 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 COVID-19. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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 be available after 6-7 month starting the study To whom: For all people and physician may have concern about COVID-19 and its management Conditions: In patients with COVID-19 as a probable adjuvant therapy in the setting of no contraindication for this drug Where to obtain: Via related published article How to obtain: Purchase published article Comments:
public Azadeh Goodarzi
Nyayesh Street, Sattarkhan Avenue, Rasoul Akram Hospital, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 009866502040 azadeh_goodarzi1984@yahoo.com Iranshahr University of Medical Sciences scientific Azadeh Goodarzi
Nyayesh Street, Sattarkhan Avenue, Rasoul Akram Hospital, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6650 2040 azadeh_goodarzi1984@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 90 years Both 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 U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs 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. 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. 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. O2 saturation. Timepoint: At the beginning of the hospitalization/ two weeks after treatment. Method of measurement: Clinical evaluation and pulse oximetery. Re-hospitalization after discharge. Timepoint: At the beginning of the hospitalization/ two weeks after treatment. Method of measurement: Clinical evaluation. Duration of hospitalization. Timepoint: After discharge. Method of measurement: Days. 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. 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. 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. Need to ICU admission. Timepoint: During hospitalization. Method of measurement: Clinical evaluation. Recovery or death. Timepoint: During hospitalization or in follow-up period. Method of measurement: Observation. Side effects. Timepoint: Time to start the intervention/ during hospitalization, two weeks after interventions. Method of measurement: Clinical, laboratory evaluation. Need change initial treatment or add new drug to the regimen. Timepoint: During hospitalization. Method of measurement: Clinical assessment. Iran University of Medical Sciences Approved 2020-08-25 Ethics committee of Iran University of medical scinces Nyayesh Street, Sattarkhan Avenue, Rasoul Akram Hospital, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)