COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002214-40/IT

OSPEDALE UNIVERSITARIO LUIGI SACCO MILANO - UO MEDICINA GENERALE

arquati.massimo@gmail.com

2021-10-18

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

- 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 - polmonite da COVID-19 con insufficienza respiratoria moderata-grave (PaO2/FiO2<250) e/o elevati valori di D-dimero (>3000 ng/mL) - consenso informato scritto valido

- 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 - età < 18 e > 80 anni - emorragia in atto o pregressa (ulcera peptica in trattamento, varici esofagee, aneurismi cerebrali, neoplasia a rischio emorragico, cirrosi epatica, ictus emorragico < 1 anno) - piastrinopenia (<100 x109/L) - anemia (Hb < 8 g/dl) - alterazioni emostasi (PT e/o aPTT > 1.5, fibrinogeno < 150 mg/dl) - coagulopatia da consumo (criteri ISTH) [15, 16] - trombosi venosa profonda e/o embolia polmonare documentata all’ingresso - duplice terapia antiaggregante - terapia anticoagulante in atto - allergia a EBPM - pregressa piastrinopenia da eparina - chirurgia maggiore < 1 mese, neurochirurgia <3 mesi, chirurgia oculistica <3 mesi (esclusa cataratta) - gravidanza - ipertensione arteriosa non controllata (PAS>160 mm Hg, PAD>100 mm Hg) - insufficienza renale definita come clearance creatinina < 30 ml/min - ricovero in rianimazione o intubazione oro-tracheale - PaO2/FiO2 >250

2

ASST FATEBENEFRATELLI SACCO

18

100

Italy

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

300

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 Efficacia: Mortalità (intraospedaliera e a 30 giorni) e numero di giorni di ventilazione a pressione positiva Sicurezza: emorragie maggiori e non maggiori ma clinicamente rilevanti

Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "Therapeutic", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Prophylactic", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]