Status:
UNKNOWN
High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Conditions:
COVID
Pneumonia, Viral
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Randomized, controlled study conducted in hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation. Aim of this study is to assess whether h...
Detailed Description
This is a multicentre, randomised controlled, open label, investigator sponsored, two arms study. The study will involve 7 Italian Academic and non-Academic Internal Medicine Units, 2 Infectious Dise...
Eligibility Criteria
Inclusion
- Inclusion Criteria (all required):
- Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material)
- Severe pneumonia defined by the presence of at least one of the following criteria:
- Respiratory Rate ≥25 breaths /min
- Arterial oxygen saturation≤93% at rest on ambient air
- PaO2/FiO2 ≤300 mmHg
- Coagulopathy, defined by the presence of at least one of the following criteria:
- D-dimer \>4 times the upper level of normal reference range
- Sepsis-Induced Coagulopathy (SIC) score \>4
- No need for invasive mechanical ventilation
- Exclusion Criteria:
- Invasive mechanical ventilation
- Thrombocytopenia (platelet count \< 80.000 mm3)
- Coagulopathy: INR \>1.5, aPTT ratio \> 1.4
- Impaired renal function (eGFR calculated by CKD-EPI Creatinine equation \< 30 ml/min)
- Known hypersensitivity to enoxaparin
- History of heparin induced thrombocytopenia
- Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant cancer at high risk of haemorrhage, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
- Concomitant anticoagulant treatment for other indications (e.g. atrial fibrillation, venous thromboembolism, prosthetic heart valves).
- Concomitant double antiplatelet therapy
- Administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; prophylactic doses are allowed
- Pregnancy or breastfeeding or positive pregnancy test
- Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition)
- Lack or withdrawal of informed consent
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04408235
Start Date
June 1 2020
End Date
June 1 2021
Last Update
May 29 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliero-Universitaria
Modena, Italy, 41124