| Trial registration number
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NCT04685655 |
Full text link
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04685655
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First author
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Christian Nusshag, MD
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Contact
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Christian.Nusshag@med.uni-heidelberg.de
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Registration date
Last imported at : Dec. 31, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2020-12-28
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Recruitment status
Last imported at : Jan. 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Recruiting
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Study design
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Single group assignment
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Masking
Last imported at : Dec. 30, 2020, 12:31 a.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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multi-center
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Study aim
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- written informed consent by the study participant or their legally appointed
representative.
- age ≥ 18 years
- evidence of acute sars-cov-2 infection, confirmed by pcr testing
- invasive ventilation
- fever ≥ 38.5°c, confirmed by a total of 3 consecutive measurements or ongoing renal
replacement therapy and temperature ≥ 37.5°c
- d-dimers ≥ 2mg/l
- dexamethasone ≥ 6mg/day or equivalent dose on at least 2 days
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Exclusion criteria
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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- age > 85 years
- pre-existing treatment limitations
- pregnancy
- confirmed pulmonary arterial embolism with hemodynamically relevant right heart strain
- st-segment elevation myocardial infarction (stemi)
- participation in an intervention study elsewhere
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Number of arms
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Heidelberg University
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Inclusion age min
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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85
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Countries
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Germany
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Type of patients
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Critical disease at enrollment
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Severity scale
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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8: Critical disease at enrollment
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Total sample size
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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228
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primary outcome
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Survival
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Notes
Last imported at : Dec. 30, 2020, 12:31 a.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 : Dec. 30, 2020, 12:31 a.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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