COVID-19 trials registries data warehouse

http://en.irct.ir/trial/46533

Farid Najafi

daftarriast@kums.ac.ir

2020-04-20

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Confirmed cases of New coronavirus infection or COVID-19 who are 18 years and older; Not more than 14 days from the onset of symptoms Bilateral lung involvement in imaging findings Moderate to severe acute respiratory distress syndrome Decreased PaO2 to FiO2 ratio

AST and ALT> 3-5x ULN at visit and bilirubin> 1.5 x ULN at visit creatinine clearance rate calculated by Cockcroft-Gault formula at visit 1 <30 mL / min Confirmed previous Idiopathic pulmonary fibrosis,previous treatment with Nidanib or Pirfenidone Significant pulmonary hypertension (PAH) Cardiovascular diseases, including any of the following diseases: ① Severe hypertension within 6 months of Visit 1, uncontrollable after treatment (≥160 / 100 mmHg); ② myocardial infarction within 6 months of visit 1; ③ unstable angina within 6 months of visit 1 history of severe central nervous system (CNS) events known trials Drug allergies Patients unable to follow the trial procedures Pregnancy Breastfeeding

2

Kermanshah University of Medical Sciences

18

None

Iran

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

40

The scales of pulmonary involvement changes according to the scoring system defined, based on high resolution pulmonary computed tomography before and after the interventions

Phase 3

[{"arm_notes": "", "treatment_id": 995, "treatment_name": "Pirfenidone", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]