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

Primary Purpose

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

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
UVA Light Emitting Catheter
Sham Control Catheter
Sponsored by
Aytu BioPharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clinic of Barcelona
  • Vall d'Hebron University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

UVA Light Emitting Catheter

Sham Control Device

Arm Description

Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2.

Sham Control Device

Outcomes

Primary Outcome Measures

Change in viral load in endotracheal tube aspirates
Difference in change in viral load from the endotracheal tube (ETT) aspirates on day 0 to the last day of treatment between treated and untreated subjects.

Secondary Outcome Measures

Overall reduction or change of endotracheal bacterial content in upper airway
Change in endotracheal bacterial content (determined by culture or PCR methodology) from the ETT aspirate on day 0 to the last day of treatment.
Days to extubation
Days to extubation
Development of ventilated associated pneumonia (VAP)
Percentage of development of VAP in between day 0 to day 7. VAP is defined by new or progressive pulmonary infiltrates on imaging along with clinical suspicion by the managing team (e.g. fever, leukocytosis, increased procalcitonin) warranting initiation or change in antibiotic therapy.
Days to discharge from hospital
Days to discharge from hospital
Mean ordinal scale on day 15
Death Hospitalized, on invasive mechanical ventilation with additional organ support, ECMO, pressors, RRT Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home-oxygen; Not hospitalized, no limitations on activities
Mean ordinal scale on day 28
Death Hospitalized, on invasive mechanical ventilation with additional organ support, ECMO, pressors, RRT Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home-oxygen; Not hospitalized, no limitations on activities
Changes in Ferritin levels (Exploratory Measure those drawn for clinical care)
Changes in Ferritin levels (4.63-204.0 ng/mL) day 0-7
Change in Interleukin-6 (IL-6) levels (Exploratory Measure those drawn for clinical care)
Changes in interleukin-6 levels (Critical value: ≥ 100 pg/mL) day 0-7
Changes in C reactive protein levels (Exploratory Measure those drawn for clinical care)
Changes in C reactive protein levels (<5 mg/L) day 0-7
Changes in White blood cell levels (Exploratory Measure those drawn for clinical care)
Changes in White blood cell levels (4.00-11.00 x 1000/UL) day 0-7
Changes in Procalcitonin levels (Exploratory Measure those drawn for clinical care)
Changes in Procalcitonin levels (<0.08 ng/mL) day 0-7
Changes in Lymphocyte counts (Exploratory Measure those drawn for clinical care)
Changes in Lymphocyte count (1.00-4.50 x 1000/UL) day 0-7
Changes in D-dimer levels (Exploratory Measure those drawn for clinical care)
Changes in D-dimer levels (0.00-0.50 µg/mL) day 0-7
Changes in Creatine Phosphokinase levels (Exploratory Measure those drawn for clinical care)
Changes in Creatine Phosphokinase levels (29-168 U/L) day 0-7
Changes in Troponin levels (Exploratory Measure those drawn for clinical care)
Changes in Troponin levels (<0.04 ng/mL) day 0-7
Overall reduction or change of SARS-CoV-2 serum viral load (Exploratory Measure)
Change in viral load for blood serum sample on day 0 through the last day of treatment (Day 0, Day 1, Day 2, etc.)

Full Information

First Posted
December 20, 2021
Last Updated
October 13, 2022
Sponsor
Aytu BioPharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05166915
Brief Title
Respiratory COVID-19: A Randomized, Sham-Controlled Study
Official Title
Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Randomized, Sham-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Indefinite hold by Company.
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aytu BioPharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia, Acute Respiratory Distress Syndrome, COVID-19 Acute Respiratory Distress Syndrome, COVID-19 Respiratory Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects will be randomized 1:1 to receive treatment with the functional UVA light catheter or the sham control device.
Masking
ParticipantCare Provider
Masking Description
Randomized, Sham Control
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UVA Light Emitting Catheter
Arm Type
Experimental
Arm Description
Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2.
Arm Title
Sham Control Device
Arm Type
Sham Comparator
Arm Description
Sham Control Device
Intervention Type
Device
Intervention Name(s)
UVA Light Emitting Catheter
Intervention Description
Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2
Intervention Type
Device
Intervention Name(s)
Sham Control Catheter
Intervention Description
Sham Control Device
Primary Outcome Measure Information:
Title
Change in viral load in endotracheal tube aspirates
Description
Difference in change in viral load from the endotracheal tube (ETT) aspirates on day 0 to the last day of treatment between treated and untreated subjects.
Time Frame
Day 0-Day 5
Secondary Outcome Measure Information:
Title
Overall reduction or change of endotracheal bacterial content in upper airway
Description
Change in endotracheal bacterial content (determined by culture or PCR methodology) from the ETT aspirate on day 0 to the last day of treatment.
Time Frame
Day 0-Day 5
Title
Days to extubation
Description
Days to extubation
Time Frame
Day 0 - Day 30
Title
Development of ventilated associated pneumonia (VAP)
Description
Percentage of development of VAP in between day 0 to day 7. VAP is defined by new or progressive pulmonary infiltrates on imaging along with clinical suspicion by the managing team (e.g. fever, leukocytosis, increased procalcitonin) warranting initiation or change in antibiotic therapy.
Time Frame
Day 0-Day7
Title
Days to discharge from hospital
Description
Days to discharge from hospital
Time Frame
Day 0 - Day 30
Title
Mean ordinal scale on day 15
Description
Death Hospitalized, on invasive mechanical ventilation with additional organ support, ECMO, pressors, RRT Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home-oxygen; Not hospitalized, no limitations on activities
Time Frame
Day 14
Title
Mean ordinal scale on day 28
Description
Death Hospitalized, on invasive mechanical ventilation with additional organ support, ECMO, pressors, RRT Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home-oxygen; Not hospitalized, no limitations on activities
Time Frame
Day 27
Title
Changes in Ferritin levels (Exploratory Measure those drawn for clinical care)
Description
Changes in Ferritin levels (4.63-204.0 ng/mL) day 0-7
Time Frame
Day 0 - Day 7
Title
Change in Interleukin-6 (IL-6) levels (Exploratory Measure those drawn for clinical care)
Description
Changes in interleukin-6 levels (Critical value: ≥ 100 pg/mL) day 0-7
Time Frame
Day 0 - Day 7
Title
Changes in C reactive protein levels (Exploratory Measure those drawn for clinical care)
Description
Changes in C reactive protein levels (<5 mg/L) day 0-7
Time Frame
Day 0 - Day 7
Title
Changes in White blood cell levels (Exploratory Measure those drawn for clinical care)
Description
Changes in White blood cell levels (4.00-11.00 x 1000/UL) day 0-7
Time Frame
Day 0 - Day 7
Title
Changes in Procalcitonin levels (Exploratory Measure those drawn for clinical care)
Description
Changes in Procalcitonin levels (<0.08 ng/mL) day 0-7
Time Frame
Day 0 - Day 7
Title
Changes in Lymphocyte counts (Exploratory Measure those drawn for clinical care)
Description
Changes in Lymphocyte count (1.00-4.50 x 1000/UL) day 0-7
Time Frame
Day 0 - Day 7
Title
Changes in D-dimer levels (Exploratory Measure those drawn for clinical care)
Description
Changes in D-dimer levels (0.00-0.50 µg/mL) day 0-7
Time Frame
Day 0 - Day 7
Title
Changes in Creatine Phosphokinase levels (Exploratory Measure those drawn for clinical care)
Description
Changes in Creatine Phosphokinase levels (29-168 U/L) day 0-7
Time Frame
Day 0 - Day 7
Title
Changes in Troponin levels (Exploratory Measure those drawn for clinical care)
Description
Changes in Troponin levels (<0.04 ng/mL) day 0-7
Time Frame
Day 0 - Day 7
Title
Overall reduction or change of SARS-CoV-2 serum viral load (Exploratory Measure)
Description
Change in viral load for blood serum sample on day 0 through the last day of treatment (Day 0, Day 1, Day 2, etc.)
Time Frame
Day 0 - Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Torres, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
State/Province
Catalan
ZIP/Postal Code
08036
Country
Spain
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
State/Province
Catalan
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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