| Trial registration number
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NCT05334654 |
Full text link
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05334654
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First author
Last imported at : Aug. 20, 2022, 7:30 p.m.
Source : ClinicalTrials.gov
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Federico Longhini
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Contact
Last imported at : Aug. 20, 2022, 7:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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2022-04-19
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Recruitment status
Last imported at : Aug. 20, 2022, 7:30 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
ratio between arterial partial pressure to inspired fraction of oxygen (pao2/fio2) < 200 mmhg
age equal or greater of 18 years/old
detection of coronavirus 2019 at the nasal swab;
need for endotracheal intubation and invasive mechanical ventilation
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Exclusion criteria
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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known allergies to one of the two investigated drugs
presence of hematological diseases
pregnancy
recent (10 days) surgery
presence of active bleeding
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Number of arms
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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University Magna Graecia
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Inclusion age min
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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Italy
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Type of patients
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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Critical disease at enrollment
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Severity scale
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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8: Critical disease at enrollment
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Total sample size
Last imported at : May 6, 2022, 5 a.m.
Source : ClinicalTrials.gov
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58
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primary outcome
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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Time spent under invasive mechanical ventilation
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Notes
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "nan", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 211, "treatment_name": "Bivalirudin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]
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