COVID-19 trials registries data warehouse

http://en.irct.ir/trial/51927

Rasoul Akram Hospital Clinical research development Center (RCRDC)

azadeh_goodarzi1984@yahoo.com

2020-11-16

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

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

2

Iran University of Medical Sciences

18

90

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

150

Time to improve symptoms such as cough, shortness of breath and lethargy O2 saturation Re-hospitalization after discharge Duration of hospitalization Evaluation of laboratory parameters as a series of factors: PCR and LDH, CBC, ESR, CRP Check for changes in anti-inflammatory parameters (TNF-ALPHA and IL-6 if measuring kits are available) Investigation of radiological changes at the beginning of hospitalization and during hospitalization if possible Need to ICU admission Recovery or death

Phase 3

[{"arm_notes": "", "treatment_id": 971, "treatment_name": "Pentoxifylline", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]