Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight heparin dosages in hospitalised patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD) - Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight he

AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA0 sites300 target enrollmentJune 26, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation.
Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA
Enrollment: 300
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

June 26, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA

•Patients admitted to the hospital with COVID\-19 confirmed by PCR test on throat swab samples, and with severe pneumonia plus coagulopathy, defined as the presence of at least one clinical and one laboratory criteria.
•Clinical criteria (at least one)
•1\) Respiratory Rate \= 25 breaths /min
•2\) Arterial oxygen saturation \= 93% at rest in room air
•3\) PaO2/FiO2 \= 300 mmHg
•Laboratory criteria and SIC score (at least one )
•1\) D\-dimer \> 4 times the upper level of normal reference range
•2\) Sepsis\-Induced Coagulopathy (SIC) score \> 4
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\.Age \< 18 and \> 80 years
•2\.Invasive ventilation
•3\.Thrombocytopenia (platelet count \< 80\.000 mm3\)
•4\.Coagulopathy: INR \>1\.5, aPTT ratio \>1\.4
•5\.Impaired renal function (eGFR by CKD\-EPI Creatinine equation \< 30 ml/min)
•6\.Known hypersensitivity to enoxaparin
•7\.History of heparin induced thrombocytopenia
•8\.Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant tumors at high risk of haemorrhages, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
•9\.Concomitant anticoagulant treatment for other indications (e.g. atrial fibrillation, venous thromboembolism, prosthetic heart valves)
•10\.Concomitant double antiplatelet therapy