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

NCT05166915 | Withdrawn DMC

• 1 other identifier: UVL-0001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0-Day 5

Secondary Outcomes (16)

• Overall reduction or change of endotracheal bacterial content in upper airway

  Day 0-Day 5

• Days to extubation

  Day 0 - Day 30

• Development of ventilated associated pneumonia (VAP)

  Day 0-Day7

• Days to discharge from hospital

  Day 0 - Day 30

• Mean ordinal scale on day 15

  Day 14

Study Arms (2)

UVA Light Emitting Catheter

EXPERIMENTAL

Experimental 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 Device

SHAM COMPARATOR

Sham Control Device

Device: Sham Control Catheter

Interventions

UVA Light Emitting Catheter DEVICE

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

UVA Light Emitting Catheter

Sham Control Catheter DEVICE

Sham Control Device

Sham Control Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent (or surrogate)
• Enrolled in a therapeutic clinical trial for COVID-19 that does not allow recruitment in other trials.

Sponsors & Collaborators

• Aytu BioPharma, Inc.: lead

Study Sites (2)

Hospital Clinic of Barcelona

Barcelona, Catalan, 08036, Spain

Location

Vall d'Hebron University Hospital

Barcelona, Catalan, 08036, Spain

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Antoni Torres, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomized, Sham Control
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 22, 2021
• Study Start: October 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)