COVID-19 trials registries data warehouse

http://en.irct.ir/trial/54937

Ebrahim Falahi

falahi.e@lums.ac.ir

2021-06-03

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

Hospitalized patients suspected to Covid19 infection SpO2 less than 93% The presence of respiratory symptoms (including shortness of breath, pain and pressure in the chest) older than 40 years

Active peptic ulcer Pregnancy and lactation History of colchicine or pentoxifylline allergy Concomitant use of protease inhibitors, strong inhibitors or inducers of CYP3A4 or pgp drugs, statin other than rosuvastatin Occurrence of side effects Fauvism History of alcohol use Retinopathy Neuromuscular disease Severe renal failure and GFR less than 30 ml/min Severe hepatic impairment (bilirubin higher than 2 mg/dL and albumin less than 2.8 g/dL) Active bleeding including intracerebral hemorrhage or retinal hemorrhage Chronic diarrhea or malabsorption History of heart disease (heart failure, ventricular arrhythmia, right or left heart block, QTc more than 480 milliseconds) Dissatisfaction with the company

2

Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences

40

100

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

Duration of hospitalization

Phase 3

[{"arm_notes": "", "treatment_id": 1662, "treatment_name": "Colchicine+pentoxifylline", "treatment_type": "Metabolic agents+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"}]