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

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ClinicalTrials.gov Identifier: NCT05166915
Recruitment Status : Withdrawn (Indefinite hold by Company.)
First Posted : December 22, 2021
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
Aytu BioPharma, Inc.

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.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Acute Respiratory Distress Syndrome COVID-19 Acute Respiratory Distress Syndrome COVID-19 Respiratory Infection Device: UVA Light Emitting Catheter Device: Sham Control Catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects will be randomized 1:1 to receive treatment with the functional UVA light catheter or the sham control device.
Masking: Double (Participant, Care Provider)
Masking Description: Randomized, Sham Control
Primary Purpose: Treatment
Official Title: Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Randomized, Sham-Controlled Study
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: UVA Light Emitting Catheter
Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2.
Device: UVA Light Emitting Catheter
Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2

Sham Comparator: Sham Control Device
Sham Control Device
Device: Sham Control Catheter
Sham Control Device




Primary Outcome Measures :
  1. Change in viral load in endotracheal tube aspirates [ Time Frame: Day 0-Day 5 ]
    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 :
  1. Overall reduction or change of endotracheal bacterial content in upper airway [ Time Frame: Day 0-Day 5 ]
    Change in endotracheal bacterial content (determined by culture or PCR methodology) from the ETT aspirate on day 0 to the last day of treatment.

  2. Days to extubation [ Time Frame: Day 0 - Day 30 ]
    Days to extubation

  3. Development of ventilated associated pneumonia (VAP) [ Time Frame: Day 0-Day7 ]
    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.

  4. Days to discharge from hospital [ Time Frame: Day 0 - Day 30 ]
    Days to discharge from hospital

  5. Mean ordinal scale on day 15 [ Time Frame: Day 14 ]
    1. Death
    2. Hospitalized, on invasive mechanical ventilation with additional organ support, ECMO, pressors, RRT
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
    6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
    7. Not hospitalized, limitation on activities and/or requiring home-oxygen;
    8. Not hospitalized, no limitations on activities

  6. Mean ordinal scale on day 28 [ Time Frame: Day 27 ]
    1. Death
    2. Hospitalized, on invasive mechanical ventilation with additional organ support, ECMO, pressors, RRT
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
    6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
    7. Not hospitalized, limitation on activities and/or requiring home-oxygen;
    8. Not hospitalized, no limitations on activities

  7. Changes in Ferritin levels (Exploratory Measure those drawn for clinical care) [ Time Frame: Day 0 - Day 7 ]
    Changes in Ferritin levels (4.63-204.0 ng/mL) day 0-7

  8. Change in Interleukin-6 (IL-6) levels (Exploratory Measure those drawn for clinical care) [ Time Frame: Day 0 - Day 7 ]
    Changes in interleukin-6 levels (Critical value: ≥ 100 pg/mL) day 0-7

  9. Changes in C reactive protein levels (Exploratory Measure those drawn for clinical care) [ Time Frame: Day 0 - Day 7 ]
    Changes in C reactive protein levels (<5 mg/L) day 0-7

  10. Changes in White blood cell levels (Exploratory Measure those drawn for clinical care) [ Time Frame: Day 0 - Day 7 ]
    Changes in White blood cell levels (4.00-11.00 x 1000/UL) day 0-7

  11. Changes in Procalcitonin levels (Exploratory Measure those drawn for clinical care) [ Time Frame: Day 0 - Day 7 ]
    Changes in Procalcitonin levels (<0.08 ng/mL) day 0-7

  12. Changes in Lymphocyte counts (Exploratory Measure those drawn for clinical care) [ Time Frame: Day 0 - Day 7 ]
    Changes in Lymphocyte count (1.00-4.50 x 1000/UL) day 0-7

  13. Changes in D-dimer levels (Exploratory Measure those drawn for clinical care) [ Time Frame: Day 0 - Day 7 ]
    Changes in D-dimer levels (0.00-0.50 µg/mL) day 0-7

  14. Changes in Creatine Phosphokinase levels (Exploratory Measure those drawn for clinical care) [ Time Frame: Day 0 - Day 7 ]
    Changes in Creatine Phosphokinase levels (29-168 U/L) day 0-7

  15. Changes in Troponin levels (Exploratory Measure those drawn for clinical care) [ Time Frame: Day 0 - Day 7 ]
    Changes in Troponin levels (<0.04 ng/mL) day 0-7

  16. Overall reduction or change of SARS-CoV-2 serum viral load (Exploratory Measure) [ Time Frame: Day 0 - Day 5 ]
    Change in viral load for blood serum sample on day 0 through the last day of treatment (Day 0, Day 1, Day 2, etc.)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05166915


Locations
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Spain
Hospital Clinic of Barcelona
Barcelona, Catalan, Spain, 08036
Vall d'Hebron University Hospital
Barcelona, Catalan, Spain, 08036
Sponsors and Collaborators
Aytu BioPharma, Inc.
Investigators
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Principal Investigator: Antoni Torres, MD Hospital Clinic of Barcelona
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Responsible Party: Aytu BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT05166915    
Other Study ID Numbers: UVL-0001
First Posted: December 22, 2021    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury