Trial Outcomes & Findings for UVA Light Device to Treat COVID-19 (NCT NCT04572399)

NCT ID: NCT04572399

Last Updated: 2025-01-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2025-01-09

Participant Flow

Participant milestones

Measure	Endotracheal UV Light Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

UVA Light Device to Treat COVID-19

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: 5 days

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

Outcome measures

Measure	Endotracheal UV Light n=5 Participants Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Negative Change in Viral Load	3.2 log10 copies/mL Interval 1.2 to 6.77

SECONDARY outcome

Timeframe: 5 days

Change of bacterial load in upper airway

Outcome measures

Measure	Endotracheal UV Light n=5 Participants Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Change in Bacterial Load	102000 Colony forming units/mL Standard Deviation 594000

SECONDARY outcome

Timeframe: 1 month

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

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

Outcome measures

Measure	Endotracheal UV Light n=5 Participants Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Ventilated Associated Pneumonia	1 Participants

SECONDARY outcome

Timeframe: 1 month

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

Number of days patient is intubated with endotracheal tube or tracheostomy

Outcome measures

Measure	Endotracheal UV Light n=4 Participants Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Days to Extubation	20.75 days Interval 6.0 to 30.0

SECONDARY outcome

Timeframe: 1 month

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

Number of days patient is discharged from the hospital

Outcome measures

Measure	Endotracheal UV Light n=4 Participants Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Days to Discharge	27.25 days Interval 19.0 to 30.0

SECONDARY outcome

Timeframe: 5 days

Change in C-reactive protein from baseline to the end of the treatment

Outcome measures

Measure	Endotracheal UV Light n=5 Participants Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Change in C-reactive Protein	95.00 mg/L Standard Deviation 48.00

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Endotracheal UV Light n=5 Participants Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated
Change in the World Health Organization (WHO) Coronavirus Disease (COVID)-19 10-point Ordinal Severity Scale by 30 Days	3.6 Scores on a scale Interval -1.0 to 7.0

SECONDARY outcome

Timeframe: 5 days

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

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

Outcome measures

Outcome data not reported

Adverse Events

Endotracheal UV Light

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melissa Hampton

Cedars-Sinai

Phone: 3104230617

Email: Melissa.Hampton@cshs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place