COVID-19 PneumoniaNCT05166915
Respiratory COVID-19: A Randomized, Sham-Controlled Study
A study testing UVA Light Emitting Catheter in people with COVID-19 Pneumonia and Acute Respiratory Distress Syndrome, run by Aytu BioPharma, Inc. at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, Acute Respiratory Distress Syndrome, COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- UVA Light Emitting Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clinic of Barcelona
Barcelona, Catalan, 08036
Vall d'Hebron University Hospital
Barcelona, Catalan, 08036
About this study
Official title: Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Randomized, Sham-Controlled Study
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.
Read the 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.
- Conditions
- COVID-19 Pneumonia, Acute Respiratory Distress Syndrome, COVID-19 Acute Respiratory Distress Syndrome, COVID-19 Respiratory Infection
- Being tested
- UVA Light Emitting Catheter, Sham Control Catheter
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVA Light Emitting CatheterDevice
Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2
Sham Control CatheterDevice
Sham Control Device
| Study group | Role | What they receive |
|---|---|---|
| UVA Light Emitting Catheter | Experimental | Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2. Receives: Device: UVA Light Emitting Catheter |
| Sham Control Device | Sham comparator | Sham Control Device Receives: Device: Sham Control Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0-Day 5
Secondary outcomes (16)
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.
Measured: Day 0-Day 5
Days to extubation
Days to extubation
Measured: Day 0 - Day 30
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.
Measured: Day 0-Day7
Days to discharge from hospital
Days to discharge from hospital
Measured: Day 0 - Day 30
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
Measured: Day 14
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
Measured: Day 27
Changes in Ferritin levels (Exploratory Measure those drawn for clinical care)
Changes in Ferritin levels (4.63-204.0 ng/mL) day 0-7
Measured: Day 0 - Day 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
Measured: Day 0 - Day 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
Measured: Day 0 - Day 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
Measured: Day 0 - Day 7
Changes in Procalcitonin levels (Exploratory Measure those drawn for clinical care)
Changes in Procalcitonin levels (<0.08 ng/mL) day 0-7
Measured: Day 0 - Day 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
Measured: Day 0 - Day 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
Measured: Day 0 - Day 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
Measured: Day 0 - Day 7
Changes in Troponin levels (Exploratory Measure those drawn for clinical care)
Changes in Troponin levels (<0.04 ng/mL) day 0-7
Measured: Day 0 - Day 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.)
Measured: Day 0 - Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study startOct 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Indefinite hold by Company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Subjects will be randomized 1:1 to receive treatment with the functional UVA light catheter or the sham control device.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aytu BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antoni Torres, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166915
- Sponsor's protocol ID
- UVL-0001
- Status last verified
- Oct 2022
- First submitted
- 20 Dec 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Randomized, Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT05166915
- Acronym / sponsor ID
- UVL-0001
- Conditions
- COVID-19 Pneumonia, Acute Respiratory Distress Syndrome, COVID-19 Acute Respiratory Distress Syndrome, COVID-19 Respiratory Infection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Indefinite hold by Company.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aytu BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Subjects will be randomized 1:1 to receive treatment with the functional UVA light catheter or the sham control device.
| Arm | Type | Receives |
|---|---|---|
| UVA Light Emitting Catheter | Experimental | Device: UVA Light Emitting CatheterExperimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2. |
| Sham Control Device | Sham comparator | Device: Sham Control CatheterSham Control Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UVA Light Emitting CatheterExperimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2 | Device | UVA Light Emitting Catheter |
| Sham Control CatheterSham Control Device | Device | Sham Control Device |
Primary outcome
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.
16 secondary outcomes
Overall reduction or change of endotracheal bacterial content in upper airway
Time frame: Day 0-Day 5
Days to extubation
Time frame: Day 0 - Day 30
Development of ventilated associated pneumonia (VAP)
Time frame: Day 0-Day7
Days to discharge from hospital
Time frame: Day 0 - Day 30
Mean ordinal scale on day 15
Time frame: Day 14
Mean ordinal scale on day 28
Time frame: Day 27
Changes in Ferritin levels (Exploratory Measure those drawn for clinical care)
Time frame: Day 0 - Day 7
Change in Interleukin-6 (IL-6) levels (Exploratory Measure those drawn for clinical care)
Time frame: Day 0 - Day 7
Changes in C reactive protein levels (Exploratory Measure those drawn for clinical care)
Time frame: Day 0 - Day 7
Changes in White blood cell levels (Exploratory Measure those drawn for clinical care)
Time frame: Day 0 - Day 7
Changes in Procalcitonin levels (Exploratory Measure those drawn for clinical care)
Time frame: Day 0 - Day 7
Changes in Lymphocyte counts (Exploratory Measure those drawn for clinical care)
Time frame: Day 0 - Day 7
Changes in D-dimer levels (Exploratory Measure those drawn for clinical care)
Time frame: Day 0 - Day 7
Changes in Creatine Phosphokinase levels (Exploratory Measure those drawn for clinical care)
Time frame: Day 0 - Day 7
Changes in Troponin levels (Exploratory Measure those drawn for clinical care)
Time frame: Day 0 - Day 7
Overall reduction or change of SARS-CoV-2 serum viral load (Exploratory Measure)
Time frame: Day 0 - Day 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Torres, MD principal investigator
Hospital Clinic of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVA Light Emitting Catheter in people with COVID-19 Pneumonia and Acute Respiratory Distress Syndrome, run by Aytu BioPharma, Inc. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in viral load in endotracheal tube aspirates (time frame: Day 0-Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.