| Trial registration number
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NCT04979221 |
Full text link
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04979221
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First author
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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Marcio M Boniatti, PhD
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Contact
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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mboniatti@hcpa.edu.br
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Registration date
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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2021-07-28
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Recruitment status
Last imported at : July 4, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : July 29, 2021, noon
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 : July 29, 2021, noon
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- positive pcr for sars-cov-2
- icu admission < 48 hours
- age 18 years or older
- need for invasive or non-invasive ventilatory support (non-invasive ventilation or
high-flow nasal cannula) < 48 hours
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Exclusion criteria
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov
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- pregnancy or breastfeeding
- refusal to sign the informed consent form
- expected death in the next 24 hours
- patients taking routinely ssri or monoamine oxidase inhibitor therapy
- impossibility of using the enteral route
- history of seizure disorder
- history of adverse reaction to antihistamines or to cyproheptadine
- readmission to the icu
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Number of arms
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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Hospital de Clinicas de Porto Alegre
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Inclusion age min
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov
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Brazil
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Type of patients
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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Critical disease at enrollment
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Severity scale
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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8: Critical disease at enrollment
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Total sample size
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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274
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primary outcome
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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Ventilatory support
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Notes
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : July 29, 2021, noon
Source : ClinicalTrials.gov
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Phase 3
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Arms
Last imported at : July 29, 2021, noon
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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