| Trial registration number
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NCT04898062 |
Full text link
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04898062
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First author
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Not reported
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Contact
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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2021-05-24
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Recruitment status
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Withdrawn
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Study design
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : May 26, 2021, 12:32 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 : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
confirmed sars cov-2 infection (pcr-test)
oxygen therapy (maximum 'high-flow' therapy)
crp plasma concentration ≥ 50 mg/l and/or
crp increase ≥ 15 mg/l within 24 h after admission.
completed informed consent and written informed consent.
legal capacity
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Exclusion criteria
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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age < 18 years
pregnancy / lactation period
invasive, mechanical ventilation
extracorporeal membrane oxygenation (ecmo)
participation in other interventional trials
extracorporeal membrane oxygenation (ecmo) support
participation in other interventional trials
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Number of arms
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Pentracor GmbH
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Inclusion age min
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Germany
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Type of patients
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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0
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primary outcome
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Necessity and duration of non-invasive/ invasive ventilation
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Notes
Last imported at : May 26, 2021, 12:32 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 : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 354, "treatment_name": "C-reactive protein apheresis", "treatment_type": "Medical device", "pharmacological_treatment": "Non 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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