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UVA Light Device to Treat COVID-19

Primary Purpose

Coronavirus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UV Light Treatment
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endotracheal UV Light

Arm Description

Mechanically ventilated patients who will receive UV Light therapy

Outcomes

Primary Outcome Measures

Change in Viral Load
Change of viral load in upper airway in patients admitted to hospital for COVID-19

Secondary Outcome Measures

Change in Bacterial Load
Change of bacterial load in upper airway
Ventilated Associated Pneumonia
Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment
Days to Extubation
Number of days patient is intubated with endotracheal tube or tracheostomy
Days to Discharge
Number of days patient is discharged from the hospital
Change in C-reactive Protein
Change in C-reactive protein from baseline to the end of the treatment
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
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

Full Information

First Posted
September 28, 2020
Last Updated
January 13, 2022
Sponsor
Cedars-Sinai Medical Center
Collaborators
Aytu BioPharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04572399
Brief Title
UVA Light Device to Treat COVID-19
Official Title
Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
December 28, 2020 (Actual)
Study Completion Date
December 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
Aytu BioPharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intubated patients with confirmed SARS-CoV-2 will receive UV light treatment to potentially reduce bacterial and viral burden.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endotracheal UV Light
Arm Type
Experimental
Arm Description
Mechanically ventilated patients who will receive UV Light therapy
Intervention Type
Device
Intervention Name(s)
UV Light Treatment
Intervention Description
UV light therapy administered while patient is mechanically ventilated
Primary Outcome Measure Information:
Title
Change in Viral Load
Description
Change of viral load in upper airway in patients admitted to hospital for COVID-19
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Change in Bacterial Load
Description
Change of bacterial load in upper airway
Time Frame
5 days
Title
Ventilated Associated Pneumonia
Description
Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment
Time Frame
1 month
Title
Days to Extubation
Description
Number of days patient is intubated with endotracheal tube or tracheostomy
Time Frame
1 month
Title
Days to Discharge
Description
Number of days patient is discharged from the hospital
Time Frame
1 month
Title
Change in C-reactive Protein
Description
Change in C-reactive protein from baseline to the end of the treatment
Time Frame
5 days
Title
Change in the World Health Organization (WHO) Coronavirus Disease (COVID)-19 10-point Ordinal Severity Scale by 30 Days
Description
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
Time Frame
1 month
Title
Catheter Tip Assessment on the Last Day of Treatment
Description
Assessment of total bacterial load on the UV catheter tip on the last day of treatment
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Chaux, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34173969
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/34173969/
Description
Peer-reviewed publication

Learn more about this trial

UVA Light Device to Treat COVID-19

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