NCT05166915

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

Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Randomized, Sham-Controlled Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Aytu BioPharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	UVA Light Emitting Catheter	Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2
DEVICE	Sham Control Catheter	Sham Control Device

Timeline

• Start date: 2022-10-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2021-12-22
• Last updated: 2022-10-14

Locations

2 sites across 1 country: Spain