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

Not Applicable

Withdrawn

• Conditions: COVID-19 Pneumonia; COVID-19 Respiratory Infection; Acute Respiratory Distress Syndrome; COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Device: UVA Light Emitting Catheter; Device: Sham Control Catheter

• Registration Number: NCT05166915
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2021-12-22
• Status Verified: 2022-10
• Study Start: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UVA Light Emitting Catheter	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 Catheter	Sham Control Device

Primary Outcome Measures

Name	Time	Method
Change in viral load in endotracheal tube aspirates	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

Name	Time	Method
Change in Interleukin-6 (IL-6) levels (Exploratory Measure those drawn for clinical care)	Day 0 - Day 7	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)	Day 0 - Day 7	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)	Day 0 - Day 7	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)	Day 0 - Day 7	Changes in Procalcitonin levels (\<0.08 ng/mL) day 0-7
Changes in Lymphocyte counts (Exploratory Measure those drawn for clinical care)	Day 0 - Day 7	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)	Day 0 - Day 7	Changes in D-dimer levels (0.00-0.50 µg/mL) day 0-7
Changes in Troponin levels (Exploratory Measure those drawn for clinical care)	Day 0 - Day 7	Changes in Troponin levels (\<0.04 ng/mL) day 0-7
Overall reduction or change of endotracheal bacterial content in upper airway	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.
Mean ordinal scale on day 15	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
Overall reduction or change of SARS-CoV-2 serum viral load (Exploratory Measure)	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.)
Days to extubation	Day 0 - Day 30	Days to extubation
Development of ventilated associated pneumonia (VAP)	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.
Days to discharge from hospital	Day 0 - Day 30	Days to discharge from hospital
Changes in Ferritin levels (Exploratory Measure those drawn for clinical care)	Day 0 - Day 7	Changes in Ferritin levels (4.63-204.0 ng/mL) day 0-7
Changes in Creatine Phosphokinase levels (Exploratory Measure those drawn for clinical care)	Day 0 - Day 7	Changes in Creatine Phosphokinase levels (29-168 U/L) day 0-7
Mean ordinal scale on day 28	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

Trial Locations

Locations (2)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Catalan, Spain

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Catalan, Spain