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

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical 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. Study hypothesis was that respiratory SARS-CoV-2 viral burden would significantly decrease following five (5) days of UVA therapy.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05166915
Study type Interventional
Source Aytu BioPharma, Inc.
Contact
Status Withdrawn
Phase N/A
Start date October 2022
Completion date December 2022
View Details
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