Respiratory COVID-19: A Randomized, Sham-Controlled Study

NCT ID: NCT05166915

Last Updated: 2022-10-14

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2022-12-31

Brief Summary

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A study of intubated critically ill patients infected with SARS-COV-2 to evaluate the safety and treatment effects of ultraviolet-A (UVA) light administered by a novel device via endotracheal tube in a first-in-human study. Study hypothesis was that respiratory SARS-CoV-2 viral burden would significantly decrease following five (5) days of UVA therapy.

Detailed Description

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The UV Respiratory Tract Light Therapy Device is intended to emit energy in the UVA region of the spectrum in intubated patients to reduce the viral burden of SARS-CoV-2 (human pathogenic coronavirus (COVID-19)) in intubated patients. The System is to be used in conjunction with the current standard of care measures.

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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COVID-19 Pneumonia Acute Respiratory Distress Syndrome COVID-19 Acute Respiratory Distress Syndrome COVID-19 Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Subjects will be randomized 1:1 to receive treatment with the functional UVA light catheter or the sham control device.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Randomized, Sham Control

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.

Group Type EXPERIMENTAL

UVA Light Emitting Catheter

Intervention Type DEVICE

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

Group Type SHAM_COMPARATOR

Sham Control Catheter

Intervention Type DEVICE

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

Intervention Type DEVICE

Sham Control Catheter

Sham Control Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients over 18 years of age
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

1. Unable to provide informed consent (or surrogate)
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aytu BioPharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Vall d'Hebron University Hospital

Barcelona, Catalan, Spain

Site Status

Countries

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Spain

Other Identifiers

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UVL-0001

Identifier Type: -

Identifier Source: org_study_id

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