COVID-19 trials registries data warehouse

http://en.irct.ir/trial/47982

Mohhamad Ali Sahraian

shariatihosp@tums.ac.ir

2020-11-02

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

A person with laboratory confirmation of COVID-19 infection clinical and radiological confirmation of ARDS The confirm case of covid-19 in patients with ARDS (PaO2/FiO2a ≤ 300 or sat o2≤ 315 mmHg (with PEEP or CPAP ≥ 5 cmH2O, or non-ventilated)

Bleeding tendency Coagulopathy (INR>1.5) Thrombocytopenia (plt< 50000) Previous hypersensitivity to Alteplase Active internal bleeding Severe uncontrolled hypertension Severe renal disease (GFR<50 ml/min) History of recent stroke Hemoptysis at admission Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years Moderate to severe liver failure (Childs-Pugh Score > 12) Major trauma in the prior 30 days Moribund patient not expected to survive the next 24 hours. No consent/inability to obtain consent

2

Tehran University of Medical Sciences

18

70

Iran

Severe disease at enrollment

6: Severe disease at enrollment

30

The difference of PaO2/FiO2 or S/F ratio between two groups [ Time Frame: 72 h after randomization Disease severity survival in patients with ARDS Time to Ventilator Free state Adverse Drug Reaction after tratment

Phase 3

[{"arm_notes": "", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1406, "treatment_name": "Alteplase+enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]