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Trial - NCT04646655


Column Value
Trial registration number NCT04646655
Full text link
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04646655

First author
Last imported at : July 27, 2023, 4 a.m.
Source : ClinicalTrials.gov

None

Contact
Last imported at : July 27, 2023, 4 a.m.
Source : ClinicalTrials.gov

None

Registration date
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-11-30

Recruitment status
Last imported at : July 27, 2023, 4 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - covid-19 related pneumonia with moderate-severe respiratory failure (pao2/fio2<250) and/or markedly increased d-dimer level (>2000 ng/ml) - signed informed consent

Exclusion criteria
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- age < 18 and > 80 yrs - history of bleeding (peptic ulcer, esophageal varices, cerebral aneurysm, cancer at high risk of bleeding, cirrhosis, hemorrhagic stroke < 1 year) - thrombocytopenia (<100 x109/l) - anemia (hb < 8 g/dl) - coagulation abnormalities (pt e/o aptt > 1.5; fibrinogen < 150 mg/dl) - consumption coagulopathy (isth criteria) [15, 16] - deep vein thrombosis or pulmonary embolism - dual antiplatelet therapy - ongoing anticoagulant therapy - allergic reaction to lmwh - previous heparin-induced thrombocytopenia - major surgery < 1 month; neurosurgery <3 months; eye surgery <3 months - pregnancy - arterial hypertension (sbps>160 mm hg; dbp>100 mm hg) - renal failure (creatinine clearance 30 ml/min) - icu admission or endotracheal intubation

Number of arms
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

ASST Fatebenefratelli Sacco

Inclusion age min
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Italy

Type of patients
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : July 27, 2023, 4 a.m.
Source : ClinicalTrials.gov

142

primary outcome
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Progression of respiratory failure;Number of major bleeding episodes;Progression of respiratory failure;Progression of respiratory failure;Mortality rate

Notes
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Prophylactic dose", "treatment_id": 465, "treatment_name": "Enoxaparin sodium", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Therapeutic dose", "treatment_id": 465, "treatment_name": "Enoxaparin sodium", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]