| Trial registration number
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NCT04725110 |
Full text link
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04725110
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First author
Last imported at : July 28, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Kelly McCormick, MBA, MSL
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Contact
Last imported at : July 28, 2023, 8 a.m.
Source : ClinicalTrials.gov
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kmmccorm@umn.edu
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Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-01-26
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Recruitment status
Last imported at : April 13, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Not recruiting
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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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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 : Jan. 29, 2021, 12:31 a.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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None
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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pregnancy
inclusion criteria:
diagnosis of sars-cov-2 with first positive test within 14 days, and,
diagnosis of ards by the berlin criteria (2012):
onset: < 7 days
chest x-ray: bilateral patchy opacities, infiltrates
mechanical vent support: peep or cpap support >= 5 cm h2o
pulmonary edema: not fully explained by cardiogenic etiology
hypoxia: pao2/fio2 ratio < 300, or o2sat/fio2 ratio < 315
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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 Minnesota
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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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80
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Countries
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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United States
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Type of patients
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Critical 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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8: Critical disease at enrollment
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Total sample size
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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250
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primary outcome
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Change Extravascular Lung Water Index
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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": 1254, "treatment_name": "T3 solution for injection", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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