| Trial registration number
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NCT04820751 |
Full text link
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04820751
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First author
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Philippe Rola, MD
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Contact
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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philippe.rola@gmail.com
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Registration date
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-03-29
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Recruitment status
Last imported at : March 14, 2023, midnight
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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unclear
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Study aim
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- men and women age 18 or older
- hospitalized and requiring medical care for covid-19
- presenting respiratory failure cause by covid 19 requiring oxygen and/or mechanical
ventilation support
- with radiographic evidence of pulmonary infiltrate
- able to give informed consent or, if unable to do so regarding the medical condition,
having relatives able of consenting for the patient
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Exclusion criteria
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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- pregnancy
- patients with pre-existing terminal condition with life expectancy < 6 months
- patients with pre-existing severe lung disease requiring home o2
- history of seizure disorder
- history of adverse reaction to antihistamines or to cyproheptadine
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Number of arms
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Ciusss de L'Est de l'Île de Montréal
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Inclusion age min
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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99
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Countries
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Type of patients
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Severe/critical disease at enrollment
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Severity scale
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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7: Severe/critical disease at enrollment
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Total sample size
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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200
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primary outcome
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Length of hospitalization;Need mechanical ventilation (Non invasive or Invasive)
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Notes
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Phase 3
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Arms
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 368, "treatment_name": "Cyproheptadine hydrochloride", "treatment_type": "Respiratory agents", "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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