| Trial registration number
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NCT04613986 |
Full text link
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04613986
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First author
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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University of Zurich
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Contact
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-11-03
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Recruitment status
Last imported at : April 9, 2023, midnight
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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unclear
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Study aim
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- proven sars-cov2 infection
- severe covid-19 (indicated by respiratory failure requiring invasive mechanical
ventilation)
- evidence of coagulopathy (indicated by d-dimer > 10 mg/l)
- evidence of systemic inflammation (crp > 100 mg/l , ferritin > 500 ng/ml)
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Exclusion criteria
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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- • participation in another study with investigational drug within the 30 days
preceding and during the present study,
- previous enrolment into the current study.
- extra corporeal membrane oxygenation (ecmo)
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Number of arms
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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University of Zurich
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Inclusion age min
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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99
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Countries
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Type of patients
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Critical disease at enrollment
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Severity scale
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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8: Critical disease at enrollment
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Total sample size
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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20
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primary outcome
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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relative ADAMTS13 deficiency
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Notes
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1000, "treatment_name": "Plasma exchange", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological 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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