UVA Light Device to Treat COVID-19

Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Pilot Study

This pilot study will assess the safety and effectiveness of UV light treatment in hospitalized patients with COVID-19.

Study Overview

• Status: Completed
• Conditions: Coronavirus
• Intervention / Treatment: Device: UV Light Treatment

Detailed Description

This is a single center, open label, pilot study. 5 adult patients, aged over 18, who are confirmed positive with SARS-CoV-2 and are newly intubed, will receive UV light treatment to reduce SARS-CoV-2 viral load.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Confirmed positive test result for SARS-CoV-2
• Mechanically ventilated
• Endotracheal tube inner diameter of at least 7.5 mm

Exclusion Criteria:

• Unable to provide informed consent (or surrogate)
• Enrolled in a therapeutic clinical trial for same condition that does not allow recruitment in other trials
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endotracheal UV Light; Mechanically ventilated patients who will receive UV Light therapy	Device: UV Light Treatment; UV light therapy administered while patient is mechanically ventilated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative Change in Viral Load	Change of viral load in upper airway in patients admitted to hospital for COVID-19	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bacterial Load	Change of bacterial load in upper airway	5 days
Ventilated Associated Pneumonia	Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment	1 month
Days to Extubation	Number of days patient is intubated with endotracheal tube or tracheostomy	1 month
Days to Discharge	Number of days patient is discharged from the hospital	1 month
Change in C-reactive Protein	Change in C-reactive protein from baseline to the end of the treatment	5 days
Change in the World Health Organization (WHO) Coronavirus Disease (COVID)-19 10-point Ordinal Severity Scale by 30 Days	The World Health Organization (WHO) COVID-19 10-point ordinal severity scale: 0 uninfected, No viral RNA detected; Asymptomatic; viral RNA detected; Ambulatory Mild disease: Symptomatic; independent; Ambulatory Mild disease: Symptomatic; assistance needed; Hospitalized: Moderate disease; no oxygen therapy; Hospitalized: Moderate disease; oxygen by mask or nasal prongs; Hospitalized: sever disease, Oxygen by non-invasive ventilation or high flow; Hospitalized: severe disease, intubation and mechanical ventilation, pO2/FiO2>=150 or SpO2/FiO2>=200; Hospitalized: severe disease, Mechanical ventilation pO2/FiO2<150(SpO2/FiO2 <200) or vasopressors; Hospitalized: severe disease, Mechanical ventilation pO2/FiO2<150 and vasopressors, dialysis or extracorporeal membrane oxygenation; Death	1 month
Catheter Tip Assessment on the Last Day of Treatment	Assessment of total bacterial load on the UV catheter tip on the last day of treatment	5 days

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: Aytu BioPharma, Inc.
• Investigators: Principal Investigator: George Chaux, MD, Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• Rezaie A, Melmed GY, Leite G, Mathur R, Takakura W, Pedraza I, Lewis M, Murthy R, Chaux G, Pimentel M. Endotracheal Application of Ultraviolet A Light in Critically Ill Patients with Severe Acute Respiratory Syndrome Coronavirus 2: A First-in-Human Study. Adv Ther. 2021 Aug;38(8):4556-4568. doi: 10.1007/s12325-021-01830-7. Epub 2021 Jun 26.

Helpful Links

• Peer-reviewed publication

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): December 28, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; Coronavirus Infections
• Other Study ID Numbers: 883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes