COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04584580

Ashraf Madkour

asfrah_madkour@yahoo.com

2020-10-14

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - all adult (>18 years) patients from both sexes with covid-19 pneumonia with positive nucleic acid test for severe acute respiratory syndrome coronavirus (sars-cov-2) hospitalized either in the ward or intensive care unit

- patients with absolute contraindication of pharmacological thromboprophylaxis and/ anticoagulation - congenital hemorrhagic disorders - hypersensitivity to heparin - personal history of heparin-induced thrombocytopenia - active major bleeding or conditions predisposing to major bleeding. major bleeding is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g.intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in haemoglobin level (hb) of ≥2g/dl in a 24h period, or c) leads to transfusion of 2 or more units of whole blood or red blood cells (13). - suspected or confirmed bacterial endocarditis - ongoing or planned therapeutic anticoagulation for any other indication - platelet count <50,000/μl within the past 24 hours or hb level <8g/dl - prothrombin time (pt) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours - activated partial thromboplastin time (aptt) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours - fibrinogen <2.0 g/l - severe renal impairment (crcl<30 ml/min) or acute kidney injury - use of dual antiplatelet therapy - pregnancy - unwillingness to consent

2

Ain Shams University

18

100

Egypt

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

50

occurrence of venous and/or arterial thrombosis;mortality

None

Phase 4

[{"arm_notes": "1 mg/kg", "treatment_id": 750, "treatment_name": "Low molecular weight heparin (lmwh)", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "<1 mg/dl <100kg Enoxaparin 40mg OD 100-150kg Enoxaparin 40mg BD >150kg Enoxaparin 60mg BD \n1-3 mg/ dl <100kg Enoxaparin 40mg BD 100-150kg Enoxaparin 80mg BD >150kg Enoxaparin 120mg BD \n>3 mg/ dl Enoxaparin 80mg BD", "treatment_id": 750, "treatment_name": "Low molecular weight heparin (lmwh)", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]