ENOXAPARIN AT PROPHYLACTIC OR THERAPEUTIC DOSES WITH MONITORING OF OUTCOMES IN SUBJECTS INFECTED WITH COVID-19

Phase 1

• Conditions: SARS-CoV-2 related pneumonia; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002214-40-IT
• Lead Sponsor: ASST FATEBENEFRATELLI SACCO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-18
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

-COVID-19 related pneumonia associated with moderate-severe respiratory failure (PaO2/FiO2<250) and/or increased D-dimer levels (>3000 ng/mL)
-signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

- age < 18 e > 80 anni
-history of bleeding (peptic ulcer, esophageal r, cerebral aneurysm, cancer at high risk of bleeding, cirrhosi, hemorragic stroke < 1 year)
-thrombocytopenia (<100 x109/L)
-anemia (Hb < 8 g/dl)
-coagulation abnormalities (PT and/or aPTT > 1.5; fibrinogen < 150 mg/dl)
-consumption coagulopathy (ISTH criteria)
-deep venous thrombosis and/or pulmonary embolism
-dual antiplatelet therapy
-anticoagulant therapy
-LMWH allergy
-heparin induced thrombocytopenia
-major surgery < 1 month; neurosurgery <3 months; eye surgery <3 months
-pregnancy
-blood arterial hypertension (SBP>160 mm Hg; DBP>100 mm Hg)
-renal failure (creatinine clearance < 30 ml/min
-ICU admission or endotracheal intubation
-PaO2/FiO2 >250

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy and safety of the use of enoxaparin prophylactic dose vs enoxaparin therapeutic dose in COVID-19 infected patients presenting moderate-severe respiratory failure (PaO2/FiO2<250) and/or markedly increased D-dimer levels;Secondary Objective: none;Primary end point(s): Efficacy: motality (during hospitalization and at 1 month) and number of days with positive pressure ventilation<br>Safety: major bleeding and non-major bat clinically relevant bleeding;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated during hospitalization and at 1 month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): (PaO2/FiO2>300) i<br>RR<20 breaths per min <br>number of transfusions with red blood cells;Timepoint(s) of evaluation of this end point: at 72 h and 7 days