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Trial - NCT05166915


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

Not reported

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Withdrawn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"}]