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Column | Value |
---|---|
Trial registration number | NCT05166915 |
Full text link
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Not reported |
Registration date
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
2021-12-22 |
Recruitment status
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Withdrawn |
Study design
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Single group assignment |
Masking
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Blind label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
Study aim
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Treatment |
Inclusion criteria
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: patients over 18 years of age confirmed positive test result for sars-cov-2 within 14d mechanically ventilated (first intubation since positive sars-cov-2 test) endotracheal tube inner diameter at least 7.5 mm |
Exclusion criteria
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
unable to provide informed consent (or surrogate) enrolled in a therapeutic clinical trial for covid-19 that does not allow recruitment in other trials. pregnant women. while not an exclusion criterion, special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, fluoroquinolone antibiotics, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange. |
Number of arms
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Aytu BioPharma, Inc. |
Inclusion age min
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Spain |
Type of patients
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Critical disease at enrollment |
Severity scale
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
8: Critical disease at enrollment |
Total sample size
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
0 |
primary outcome
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Change in viral load in endotracheal tube aspirates |
Notes
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Not reported |
Arms
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 2089, "treatment_name": "Uva light emitting catheter", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |