| Trial registration number
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NCT04348656 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04348656
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First author
Last imported at : March 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Donald M Arnold
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Contact
Last imported at : March 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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arnold@mcmaster.ca
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-04-16
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Recruitment status
Last imported at : June 27, 2021, 2:30 a.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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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 : 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:
- ≥16 years old (>18 years of age in the united states)
- admitted to hospital with confirmed covid-19 respiratory illness
- receiving supplemental oxygen
- 500 ml of abo compatible convalescent plasma is available
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Exclusion criteria
Last imported at : Nov. 2, 2021, 12:30 p.m.
Source : ClinicalTrials.gov
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- onset of respiratory symptoms >12 days prior to randomization
- intubated or plan in place for intubation
- plasma is contraindicated (e.g. history of anaphylaxis from transfusion)
- decision in place for no active treatment
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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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Hamilton Health Sciences Corporation
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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16
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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 : March 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Brazil;Canada;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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No restriction on type of patients
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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0: No restriction on type of patients
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Total sample size
Last imported at : June 27, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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940
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primary outcome
Last imported at : March 4, 2022, 9 p.m.
Source : ClinicalTrials.gov
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Number of Participants Who Were Intubated or Died
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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 : April 13, 2022, 11:30 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": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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