| Trial registration number
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NCT04447404 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04447404
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First author
Last imported at : March 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Robert Gordon, MD
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Contact
Last imported at : March 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-06-25
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Recruitment status
Last imported at : March 25, 2021, 12:31 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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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 : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- hospitalized with moderate, severe, or early critical covid-19 illness diagnosed by
rt- pcr
- acute liver injury (including acute on chronic liver disease) or acute kidney injury
or moderate covid-19 pneumonia
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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- critical covid-19 illness (map < 60 mm hg, on mechanical ventilator for ≥ 5 days)
- on maintenance hemodialysis or peritoneal dialysis
- child pugh c cirrhosis
- hepatorenal syndrome
- ascites and/or hepatic encephalopathy
- history of end stage renal disease or ckd with egfr < 15 ml/min/1.73m2
- women who are pregnant or breast feeding
- receipt of other concomitant experimental therapies
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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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Durect
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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80
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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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Moderate/severe/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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5: Moderate/severe/critical disease at enrollment
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Total sample size
Last imported at : March 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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primary outcome
Last imported at : Aug. 6, 2022, 5 p.m.
Source : ClinicalTrials.gov
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Composite Endpoint of Alive and Free of Organ Failure at Day 28
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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 2
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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": 1960, "treatment_name": "Dur-928", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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