UVA Light Device to Treat COVID-19

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04572399
• Collaborator: Aytu BioPharma, Inc. (Industry)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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.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: Oct 30, 2020
• Actual Primary Completion Date: Dec 28, 2020
• Actual Study Completion Date: Dec 28, 2020

Arms and Interventions

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

Primary Outcome Measures

1. Change in Viral Load [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 [5 days]

   Change of bacterial load in upper airway

2. Ventilated Associated Pneumonia [1 month]

   Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment

3. Days to Extubation [1 month]

   Number of days patient is intubated with endotracheal tube or tracheostomy

4. Days to Discharge [1 month]

   Number of days patient is discharged from the hospital

5. Change in C-reactive Protein [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 [1 month]

   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

7. Catheter Tip Assessment on the Last Day of Treatment [5 days]

   Assessment of total bacterial load on the UV catheter tip on the last day of treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Cedars-Sinai Medical Center
• Aytu BioPharma, Inc.

Investigators

• Principal Investigator: George Chaux, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 30, 2020

More Information

Additional Information:

• Peer-reviewed publication

Publications

None provided.

• Responsible Party: George Chaux, Medical Director, Lung Transplant Program, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT04572399
• Other Study ID Numbers: 883
• First Posted: Oct 1, 2020
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Coronavirus Infections

Study Results

Participant Flow

Arm/Group Title	Endotracheal UV Light
Arm/Group Description	Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Endotracheal UV Light
Arm/Group Description	Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 80%
>=65 years	1 20%
Sex: Female, Male (Count of Participants)
Female	2 40%
Male	3 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 60%
Not Hispanic or Latino	2 40%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 20%
White	4 80%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	5 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endotracheal UV Light
Arm/Group Description	Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Measure Participants	5
Mean (Full Range) [log10 copies/mL]	3.2

2. Secondary Outcome

Title	Change in Bacterial Load
Description	Change of bacterial load in upper airway
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endotracheal UV Light
Arm/Group Description	Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Measure Participants	5
Mean (Standard Deviation) [Colony forming units/mL]	102000 (594000)

3. Secondary Outcome

Title	Ventilated Associated Pneumonia
Description	Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

One case of probable ventilator associated pneumonia with purulent endotracheal secretions and positive endotracheal culture for Pseudomonas aeruginosa.

Arm/Group Title	Endotracheal UV Light
Arm/Group Description	Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Measure Participants	5
Count of Participants [Participants]	1 20%

4. Secondary Outcome

Title	Days to Extubation
Description	Number of days patient is intubated with endotracheal tube or tracheostomy
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Mean days of intubation within the first 30 days of therapy. Deceased patient was not included.

Arm/Group Title	Endotracheal UV Light
Arm/Group Description	Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Measure Participants	4
Mean (Full Range) [days]	20.75

5. Secondary Outcome

Title	Days to Discharge
Description	Number of days patient is discharged from the hospital
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Mean number days for the patients to be discharged from the hospital within the first 30 days. Deceased patient was not included.

Arm/Group Title	Endotracheal UV Light
Arm/Group Description	Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Measure Participants	4
Mean (Full Range) [days]	27.25

6. Secondary Outcome

Title	Change in C-reactive Protein
Description	Change in C-reactive protein from baseline to the end of the treatment
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endotracheal UV Light
Arm/Group Description	Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Measure Participants	5
Mean (Standard Deviation) [mg/L]	95.00 (48.00)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endotracheal UV Light
Arm/Group Description	Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Measure Participants	5
Mean (Full Range) [Scores on a scale]	3.6

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Catheter tips could not be retrieved in a sterile fashion due to infectious disease protocols in ICU. Therefore, data were not collected.

Arm/Group Title	Endotracheal UV Light
Arm/Group Description	Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Measure Participants	0

Adverse Events

Time Frame	Up to 30 following enrollment.
Adverse Event Reporting Description	No treatment-emergent adverse events or need for treatment cessation was observed in the study. Oxygen saturations and hemodynamics during all treatment sessions remained stable. No subject experienced pneumothorax, subcutaneous emphysema, or ET tube dislodgment. All subjects survived except study subject 2, who was placed on comfort care following ICH due to ECMO-associated anticoagulation and died on ICU day 17. This complication was not related to study treatment.
Arm/Group Title	Endotracheal UV Light
Arm/Group Description	Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated No treatment-emergent adverse events or need for treatment cessation was observed in the study. Oxygen saturations and hemodynamics during all treatment sessions remained stable. None of the subjects experienced pneumothorax, subcutaneous emphysema, venous thromboembolism, or endotracheal tube (ETT) dislodgment.
All Cause Mortality
	Endotracheal UV Light
	Affected / at Risk (%)	# Events
Total	1/5 (20%)
Serious Adverse Events
	Endotracheal UV Light
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Endotracheal UV Light
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.