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UVA Light Device to Treat COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04572399
Recruitment Status : Completed
First Posted : October 1, 2020
Results First Posted : January 18, 2022
Last Update Posted : January 18, 2022
Sponsor:
Collaborator:
Aytu BioPharma, Inc.
Information provided by (Responsible Party):
George Chaux, Cedars-Sinai Medical Center

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

Condition or disease Intervention/treatment Phase
Coronavirus Device: UV Light Treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Pilot Study
Actual Study Start Date : October 30, 2020
Actual Primary Completion Date : December 28, 2020
Actual Study Completion Date : December 28, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Viral Load [ Time Frame: 5 days ]
    Change of viral load in upper airway in patients admitted to hospital for COVID-19


Secondary Outcome Measures :
  1. Change in Bacterial Load [ Time Frame: 5 days ]
    Change of bacterial load in upper airway

  2. Ventilated Associated Pneumonia [ Time Frame: 1 month ]
    Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment

  3. Days to Extubation [ Time Frame: 1 month ]
    Number of days patient is intubated with endotracheal tube or tracheostomy

  4. Days to Discharge [ Time Frame: 1 month ]
    Number of days patient is discharged from the hospital

  5. Change in C-reactive Protein [ Time Frame: 5 days ]
    Change in C-reactive protein from baseline to the end of the treatment

  6. Change in the World Health Organization (WHO) Coronavirus Disease (COVID)-19 10-point Ordinal Severity Scale by 30 Days [ Time Frame: 1 month ]

    The World Health Organization (WHO) COVID-19 10-point ordinal severity scale:

    0 uninfected, No viral RNA detected

    1. Asymptomatic; viral RNA detected
    2. Ambulatory Mild disease: Symptomatic; independent
    3. Ambulatory Mild disease: Symptomatic; assistance needed
    4. Hospitalized: Moderate disease; no oxygen therapy
    5. Hospitalized: Moderate disease; oxygen by mask or nasal prongs
    6. Hospitalized: sever disease, Oxygen by non-invasive ventilation or high flow
    7. Hospitalized: severe disease, intubation and mechanical ventilation, pO2/FiO2>=150 or SpO2/FiO2>=200
    8. Hospitalized: severe disease, Mechanical ventilation pO2/FiO2<150(SpO2/FiO2 <200) or vasopressors
    9. Hospitalized: severe disease, Mechanical ventilation pO2/FiO2<150 and vasopressors, dialysis or extracorporeal membrane oxygenation
    10. Death

  7. Catheter Tip Assessment on the Last Day of Treatment [ Time Frame: 5 days ]
    Assessment of total bacterial load on the UV catheter tip on the last day of treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572399


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Aytu BioPharma, Inc.
Investigators
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Principal Investigator: George Chaux, MD Cedars-Sinai Medical Center
  Study Documents (Full-Text)

Documents provided by George Chaux, Cedars-Sinai Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] September 30, 2020

More Information
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Additional Information:

Publications of Results:

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Responsible Party: George Chaux, Medical Director, Lung Transplant Program, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04572399    
Other Study ID Numbers: 883
First Posted: October 1, 2020    Key Record Dates
Results First Posted: January 18, 2022
Last Update Posted: January 18, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Infections