| Trial registration number
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NCT04361253 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04361253
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First author
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov
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Richard Kaufman, MD
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Contact
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov
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rmkaufman@bwh.harvard.edu
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-04-24
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Recruitment status
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov
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Terminated
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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 : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
age >1 year.
active covid-19 infection confirmed by positive sars-cov-2 pcr.
meets institutional criteria for admission to hospital for covid-19.
admitted to icu or non-icu floor within 5 days of enrollment.
pao2/fio2 >200 mmhg if intubated.
patient or lar able to provide informed consent.
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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previous treatment with convalescent plasma for covid-19.
current use of investigational antiviral therapy targeting sars-cov-2.
history of anaphylactic transfusion reaction.
clinical diagnosis of acute decompensated heart failure.
objection to blood transfusion.
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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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Brigham and Women's Hospital
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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1
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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United States
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Type of patients
Last imported at : Oct. 26, 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 : Oct. 26, 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 : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov
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45
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Modified WHO Ordinal Scale (MOS) score
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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 3
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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": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "Standard Plasma (FFP)", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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