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

NCT05166915 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-10-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Aytu BioPharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Antoni Torres, MD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05166915 on ClinicalTrials.gov