| Trial registration number
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NCT05018975 |
Full text link
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05018975
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First author
Last imported at : Nov. 23, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Ashra Tugung, BSc
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Contact
Last imported at : Nov. 23, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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atugung@llu.edu
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Registration date
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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2021-08-24
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Recruitment status
Last imported at : Nov. 23, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Withdrawn
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Study design
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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unclear
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Study aim
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- provision of signed and dated informed consent form
- stated willingness to comply with all study procedures and availability for the
duration of the study.
- male or female, aged 18-85
- diagnosed with q-pcr confirmed infection with sars-cov-2 virus and admitted to the
hospital.
- receiving non-invasive respiratory support through a nasal cannula or a face mask.
- ability to take oral medication and be willing to adhere to the tazemetostat regimen.
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Exclusion criteria
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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- unable to take po medication.
- need for intubation or ecmo.
- pregnancy or lactation
- known allergic reactions to tazemetostat.
- active malignancy (not in remission).
- treatment with another investigational drug.
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Number of arms
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 23, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Loma Linda University
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Inclusion age min
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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85
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Countries
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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None
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Type of patients
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Aug. 25, 2021, 7:30 p.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. 23, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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0
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primary outcome
Last imported at : Nov. 23, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Length of hospital stay
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Notes
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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Phase 2
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Arms
Last imported at : Aug. 25, 2021, 7:30 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1810, "treatment_name": "Tazemetostat", "treatment_type": "Others pharmacological treatment", "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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