| Trial registration number
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NCT04371367 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04371367
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First author
Last imported at : Jan. 14, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Emilie Garrido-Pradalie
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Contact
Last imported at : Jan. 14, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Nicolas SCHLEINITZ, nicolas.schleinitz@ap-hm.fr (PI email not reported)
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-05-01
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Recruitment status
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- covid-19 severe pneumonia patients need for oxygen therapy ≥ 5 l/min or high-flow
oxygen therapy
- covid-19 related acute respiratory distress syndrome (ards) requiring mechanical
ventilation
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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- pregnant woman
- uncontrolled sepsis of bacterial or fungal origin
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Assistance Publique Hopitaux De Marseille
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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80
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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France
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Severe/critical disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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7: Severe/critical disease at enrollment
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Total sample size
Last imported at : Jan. 14, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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208
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Number of ventilator-free days at Day 28 (VFD28);Clinical improvement using WHO ordinal scale
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
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Phase 2
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 153, "treatment_name": "Avdoralimab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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