| Trial registration number
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NCT04643678 |
Full text link
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04643678
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First author
Last imported at : Aug. 17, 2022, 7 p.m.
Source : ClinicalTrials.gov
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Not reported
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Contact
Last imported at : Aug. 17, 2022, 7 p.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2020-11-25
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Recruitment status
Last imported at : Aug. 17, 2022, 7 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Nov. 27, 2020, 12:31 a.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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single-center
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Study aim
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- hospitalized adult (age ≥ 18yrs)
- confirmed covid-19 diagnosis
- presence of respiratory distress in addition to signs of cytokine release syndrome
- radiological evidence of pneumonia
- signed informed consent
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Exclusion criteria
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
- known allergic reactions to the study medication or any component of the product.
- active bacterial, viral, tb, fungal infectious diseases
- received immunosuppressant or immunomodulatory in the past 30 days
- neutrophil count < 500 cells/microliter
- platelets < 50,000/microliter
- pregnant or breastfeeding females
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Number of arms
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Hamad Medical Corporation
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Inclusion age min
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Qatar
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Type of patients
Last imported at : Nov. 27, 2020, 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 : Nov. 27, 2020, 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 : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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80
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primary outcome
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment Success at day 14
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Notes
Last imported at : Nov. 27, 2020, 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/Phase 3
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Arms
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 83, "treatment_name": "Anakinra", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological 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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