NCT04584580.

Study name	D‐dimer adjusted versus therapeutic dose low‐molecular‐weight heparin in patients with COVID‐19 pneumonia
Starting date	1 August 2020
Contact information	Ashraf Madkour Faculty of Medicine Ain Shams University Research Institute‐ Clinical Research Center Cairo, Non‐US, Egypt, 11566 +20 100 177 0703 | asfrah_madkour@yahoo.com
Methods	Single‐blinded, parallel‐assignment RCT
Participants	50 participants, ≥ 18 years, female and male Inclusion criteria: All adult (> 18 years) patients from both sexes with COVID‐19 pneumonia with positive nucleic acid test for SARS‐CoV‐2 hospitalised either in the ward or ICU Exclusion criteria: Patients with absolute contraindication of pharmacological thromboprophylaxis and/anticoagulation Congenital haemorrhagic 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 ≥ 2 g/dL in a 24 h period, or c) leads to transfusion of ≥ 2 units of whole blood or red blood cells Suspected or confirmed bacterial endocarditis Ongoing or planned therapeutic anticoagulation for any other indication Platelet count < 50,000/μL within the past 24 h or Hb level < 8 g/dL Prothrombin time (PT) ≥ 2 seconds above the upper limit of age‐appropriate local reference range within the past 24 h aPTT ≥ 4 seconds above the upper limit of age‐appropriate local reference range within the past 24 h 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
Interventions	Experimental: D‐dimer levels and weight adjusted LMWH therapy from admission until the end of hospital stay. Patients will be stratified according to their body weight and D‐dimer level and receive LMWH D‐Dimer level body weight LMWH dose < 1 mg/dL <100 kg enoxaparin 40 mg OD 100‐150 kg enoxaparin 40 mg twice daily > 150 kg enoxaparin 60 mg twice daily 1‐3 mg/dL < 100 kg enoxaparin 40 mg twice daily 100‐150 kg enoxaparin 80 mg twice daily > 150 kg enoxaparin 120 mg twice daily > 3 mg/dL enoxaparin 80 mg twice daily Comparator: therapeutic‐dose LMWH Therapeutic‐dose LMWH from admission until the end of hospital stay enoxaparin 1 mg/kg SC every 12 h
Outcomes	Primary Mortality (time frame: until patient is discharged or up to 4 weeks whichever comes first) Occurrence of venous and/or arterial thrombosis (time frame: until patient is discharged or up to 4 weeks whichever comes first) Secondary Occurrence of sepsis‐induced coagulopathy (time frame: until patient is discharged or up to 4 weeks whichever comes first) Occurrence of ARDS (time frame: until patient is discharged or up to 4 weeks whichever comes first) Occurrence of sepsis (time frame: until patient is discharged or up to 4 weeks whichever comes first) ICU admission and need for mechanical ventilation (time frame: until patient is discharged or up to 4 weeks whichever comes first)
Notes	NCT04584580 | No data provided