| Trial registration number
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NCT05184205 |
Full text link
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05184205
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First author
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov
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Josepmaria Argemi, MD
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Contact
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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2022-01-11
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Recruitment status
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Jan. 12, 2022, 9 a.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 ≥ 18 years of age
patient showing a positive test for sars-cov-2 with < 26 ct of an fda-approved pcr test who is symptomatic or flu-like illness or pneumonia
ability to tolerate an 12-minute non-painful nasal light illumination
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Exclusion criteria
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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inability to tolerate insertion of the light illuminator due to oronasal size, shape, or anatomical variants
known allergic reactions to components of the nasal decolonization treatment including methylene blue or chlorhexidine gluconate.
covid-19 illness that is moderate or severe in nature.
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Number of arms
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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Ondine Biomedical Inc.
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Inclusion age min
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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Spain
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Type of patients
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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Mild disease at enrollment
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Severity scale
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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1: Mild disease at enrollment
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Total sample size
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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100
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primary outcome
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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SARS-CoV-2 viral titer reduction
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Notes
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "nasal photodisinfection", "treatment_id": 984, "treatment_name": "Photodynamic", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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