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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
Last Update Posted : December 30, 2020
Sponsor:
Collaborator:
Aytu BioScience, Inc.
Information provided by (Responsible Party):
George Chaux, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE September 28, 2020
First Posted Date  ICMJE October 1, 2020
Last Update Posted Date December 30, 2020
Actual Study Start Date  ICMJE October 30, 2020
Actual Primary Completion Date December 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2020)
Change in viral load [ Time Frame: 5 days ]
Change of viral load in upper airway in patients admitted to hospital for COVID-19
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2020)
  • Change in bacterial load [ Time Frame: 5 days ]
    Change of bacterial load in upper airway
  • Ventilated associated pneumonia [ Time Frame: 1 month ]
    Percentage of patients developing ventilated pneumonia (VAP)
  • Days to extubation [ Time Frame: 1 month ]
    Number of days patient is intubated
  • Days to discharge [ Time Frame: 1 month ]
    Number of days patient is discharged
  • Change in C-reactive protein [ Time Frame: 5 days ]
    Change in C-reactive protein
  • 7-point clinical outcome [ Time Frame: 1 month ]
    Change in 7-point clinical outcome: 7- Death, 6-Hospitalized on ventilatory or ECMO, 5-Hospitalized on non-invasive ventilation, 4-Hospitalized on supplemental O2, 3-Hospitalized not on O2, 2-Not hospitalized but with limitations, 1-Not hospitalized and no limitations
  • Catheter tip assessment [ Time Frame: 5 days ]
    Assessment of total bacterial load on the UV catheter tip on the last day of treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UVA Light Device to Treat COVID-19
Official Title  ICMJE Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Coronavirus
Intervention  ICMJE Device: UV Light Treatment
UV light therapy administered while patient is mechanically ventilated
Study Arms  ICMJE Experimental: Endotracheal UV Light
Mechanically ventilated patients who will receive UV Light therapy
Intervention: Device: UV Light Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2020)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 28, 2020
Actual Primary Completion Date December 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04572399
Other Study ID Numbers  ICMJE 883
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party George Chaux, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Aytu BioScience, Inc.
Investigators  ICMJE
Principal Investigator: George Chaux, MD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP