Respiratory COVID-19: A Randomized, Sham-Controlled Study
NCT ID: NCT05166915
Last Updated: 2022-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-10-31
2022-12-31
Brief Summary
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Detailed Description
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The UV Respiratory Tract Light Therapy Device is intended to be used for 20 minutes per 24-hour period for the endotracheal application for 5 days, in combination with pharmacological and/or physical measures to optimize the therapeutic outcome.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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UVA Light Emitting Catheter
Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2.
UVA Light Emitting Catheter
Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2
Sham Control Device
Sham Control Device
Sham Control Catheter
Sham Control Device
Interventions
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UVA Light Emitting Catheter
Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2
Sham Control Catheter
Sham Control Device
Eligibility Criteria
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Inclusion Criteria
2. Confirmed positive test result for SARS-CoV-2 within 14d
3. Mechanically ventilated (first intubation since positive SARS-CoV-2 test)
4. Endotracheal tube inner diameter at least 7.5 mm
Exclusion Criteria
2. Enrolled in a therapeutic clinical trial for COVID-19 that does not allow recruitment in other trials.
3. 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.
18 Years
ALL
No
Sponsors
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Aytu BioPharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Antoni Torres, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital Clinic of Barcelona
Barcelona, Catalan, Spain
Vall d'Hebron University Hospital
Barcelona, Catalan, Spain
Countries
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Other Identifiers
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UVL-0001
Identifier Type: -
Identifier Source: org_study_id
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