| Trial registration number
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NCT04743349 |
Full text link
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04743349
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First author
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Giancarlo la Marca, PharmSc
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Contact
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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giancarlo.lamarca@meyer.it
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Registration date
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-02-08
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Recruitment status
Last imported at : Aug. 30, 2022, 9:30 p.m.
Source : ClinicalTrials.gov
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Terminated
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Study design
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Feb. 11, 2021, 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 : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- adults with a sars-cov-2 positive molecular swab carried out in the previous 48 hours
before the enrollement
- adults with mild infection
- adults with symptoms such as fever above 37 ° c, feeling bad, cold symptoms (cough,
pharyngodynia, nasal congestion), headache, myalgia, diarrhea, anosmia, dysgeusia
- adults without the above symptoms
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Exclusion criteria
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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- adults with dyspnea and/or dehydration and/or alterations in consciousness and/or
sepsis.
- subjects with severe asthma
- subjects and with contraindications to treatment with steam inhalations
- multi-allergic subjects
- subjects unable to complete the protocol
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Number of arms
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Feb. 17, 2023, noon
Source : ClinicalTrials.gov
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Meyer Children's Hospital IRCCS
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Inclusion age min
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Italy
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Type of patients
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Mild disease at enrollment
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Severity scale
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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1: Mild disease at enrollment
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Total sample size
Last imported at : Aug. 30, 2022, 9:30 p.m.
Source : ClinicalTrials.gov
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143
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primary outcome
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Reduction in viral shedding
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Notes
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Feb. 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1238, "treatment_name": "Steam", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non 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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