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

ENOXAPARIN AT PROPHYLACTIC OR THERAPEUTIC DOSES WITH MONITORING OF OUTCOMES IN SUBJECTS INFECTED WITH COVID-19: PILOT STUDY ON 300 CASES ENROLLED AT ASST FBF SACCO - EMOS-COVID

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002214-40-IT

Enrollment

300

Registered

2021-10-18

Start date

2020-05-20

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 related pneumonia

Interventions

Product Name: Enoxaparina Product Code: [Enoxaparina] Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ENOXAPARINA SODICA CAS Number: 679809-58-6 Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - COVID-19 related pneumonia associated with moderate-severe respiratory failure (PaO2/FiO23000 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

Exclusion criteria: - age 80 anni - history of bleeding (peptic ulcer, esophageal r, cerebral aneurysm, cancer at high risk of bleeding, cirrhosi, hemorragic stroke 1.5; fibrinogen 160 mm Hg; DBP>100 mm Hg) - renal failure (creatinine clearance 250

Design outcomes

Primary

Measure	Time frame
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 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	—

Measure

Time frame

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 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

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

Countries

Italy

Contacts

Public ContactUO MEDICINA GENERALE

OSPEDALE UNIVERSITARIO LUIGI SACCO MILANO

arquati.massimo@gmail.com0239042566

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026