| Trial registration number
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NCT05262309 |
Full text link
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05262309
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First author
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Contact
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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2022-03-02
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Recruitment status
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Open 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 : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
documented covid-19 infection
age >=18 to <=80 years
interstitial pneumonia (findings of consolidation or ground glass opacities as assessed by chest hrct)
respiratory distress, defined as pao2/fio2 ratio of >=100 <=300 mmhg, requiring supplemental oxygen and hospitalization
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Exclusion criteria
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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invasive mechanical ventilation at screening
pregnancy
incapacity to express a valid informed consent
known hypersensitivity to monoclonal antibodies used as experimental drugs for any clinical indication
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Number of arms
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Inclusion age min
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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80
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Countries
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Italy
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Type of patients
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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42
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primary outcome
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Proportion of patients not on ventilatory support
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Notes
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Phase 2/Phase 3
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Arms
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 957, "treatment_name": "Pamrevlumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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