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Trial - NCT04362111


Column Value
Trial registration number NCT04362111
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04362111

First author
Last imported at : Sept. 2, 2021, 9 p.m.
Source : ClinicalTrials.gov

Walter W Chatham, MD

Contact
Last imported at : Sept. 2, 2021, 9 p.m.
Source : ClinicalTrials.gov

wchatham@uabmc.edu

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-24

Recruitment status
Last imported at : Aug. 26, 2023, 4 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

inclusion criteria: 18 years old or older molecular (pcrna) diagnosis of sars-cov-2 infection chest imaging studies consistent with covid-19 pneumonia hyperferritinemia (>700 ng/ml) history of fever >38 degrees c any three of the following: elevated d-dimer (> 500 ng/ml) thrombocytopenia (< 130,000/mm3) leucopenia (wbc <3500/mm3) or lymphopenia (<1000/mm3) elevated ast or alt (> 2x uln) elevated ldh (> 2x uln) crp > 100 mg/l

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

participation in other investigational treatment protocols for covid-19 infection culture confirmed active bacterial infection requiring antibiotic therapy on mechanical ventilation previous known hypersensitivity reaction to anakinra previous known hypersensitivity reaction to e coli derived proteins pregnant or breast-feeding females

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

University of Alabama at Birmingham

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Aug. 26, 2023, 4 a.m.
Source : ClinicalTrials.gov

32

primary outcome
Last imported at : Aug. 26, 2023, 4 a.m.
Source : ClinicalTrials.gov

Subjects Discharged From the Hospital Alive and Without the Need for Mechanical Ventilation.

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 83, "treatment_name": "Anakinra", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]