Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT04408235
Eligibility Criteria:
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:
1. Respiratory Rate ≥25 breaths /min
2. Arterial oxygen saturation≤93% at rest on ambient air
3. PaO2/FiO2 ≤300 mmHg
* Coagulopathy, defined by the presence of at least one of the following criteria:
1. D-dimer \>4 times the upper level of normal reference range
2. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04408235
Study Brief:
Protocol Section:
NCT04408235