| Trial registration number
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NCT04635605 |
Full text link
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04635605
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First author
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Andreas Cerny, Prof
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Contact
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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andreas.cerny@hin.ch
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Registration date
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2020-11-19
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Recruitment status
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov
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Not recruiting
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Study design
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Blind 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. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria are:
- signed informed consent
- age ≥ 18 years
- microbiologically confirmed sars-cov-2 infection
- negative pregnancy test in women of child-bearing age
exclusion criteria are:
- documented refusal to participate in the study
- known g-6-phophatase deficiency
- treatment with a serotoninergic drug
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Exclusion criteria
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Number of arms
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Fondazione Epatocentro Ticino
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Inclusion age min
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Switzerland
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Type of patients
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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No restriction on type of patients
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Severity scale
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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0: No restriction on type of patients
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Total sample size
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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64
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primary outcome
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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to compare the viral load kinetics in the enrolled patients with a SARS-CoV-2 positive nasopharyngeal swab demonstrating a reduction of the area under the curve day 0- day 21 of at least 25%
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Notes
Last imported at : Nov. 21, 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
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Arms
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 797, "treatment_name": "Methylene blue", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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