| Trial registration number
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NCT04723589 |
Full text link
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04723589
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First author
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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Karen N Brown, MSHA
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Contact
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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karenbrown@uabmc.edu
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Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-01-25
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Recruitment status
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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Withdrawn
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Study design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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unclear
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Study aim
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- 18 years of age or older
- covid-19 positive by pcr or assay within 72 hours or less
- oxygen saturation of ≤94% on room air or requiring supplemental oxygen at screening
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Exclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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- mechanically ventilated
- pregnant
- prisoners
- receiving resuscitation with blood products for hemorrhagic shock
- receiving an investigational therapy for covid-19
- diagnosed with severe comorbidities
- not expected to survive more than 24 hours
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Number of arms
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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University of Alabama at Birmingham
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Inclusion age min
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Type of patients
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Jan. 29, 2021, 12:31 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 : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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0
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primary outcome
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Number of participants completing plasma infusion for COVID-19;Number of participants intubated
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Notes
Last imported at : Jan. 29, 2021, 12:31 a.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 2
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Arms
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 901, "treatment_name": "Non convalescent plasma", "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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