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CompletedNCT04572399Updated Jan 9, 2025Results posted

UVA Light Device to Treat COVID-19

An interventional study of UV Light Treatment in Coronavirus, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-09.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Coronavirus
03

In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's enrollment of 5 is below the median of 107 across 541 interventional studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Endotracheal UV Light

    Mechanically ventilated patients who will receive UV Light therapy

    Device: UV Light Treatment

Interventions

  • DeviceUV Light Treatment

    UV light therapy administered while patient is mechanically ventilated

06

What researchers measure

Primary outcomes

  1. Negative Change in Viral Load

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

    Time frame: 5 days

Secondary outcomes

  1. Change in Bacterial Load

    Change of bacterial load in upper airway

    Time frame: 5 days

  2. Ventilated Associated Pneumonia

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

    Time frame: 1 month

  3. Days to Extubation

    Number of days patient is intubated with endotracheal tube or tracheostomy

    Time frame: 1 month

  4. Days to Discharge

    Number of days patient is discharged from the hospital

    Time frame: 1 month

  5. Change in C-reactive Protein

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

    Time frame: 5 days

  6. 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 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

    Time frame: 1 month

  7. 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

    Time frame: 5 days

07

Results

Posted Jan 18, 2022

Participant flow

Participant flow — Overall Study
MilestoneEndotracheal UV Light
Started5
Completed5
Not completed0

Outcome measures

PrimaryNegative Change in Viral Load

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

Time frame:
5 days
Reported as:
Mean · log10 copies/mL
Negative Change in Viral Load
log10 copies/mLEndotracheal UV Light
Negative Change in Viral Load3.2 (1.20 to 6.77)
SecondaryChange in Bacterial Load

Change of bacterial load in upper airway

Time frame:
5 days
Reported as:
Mean · Colony forming units/mL
Change in Bacterial Load
Colony forming units/mLEndotracheal UV Light
Change in Bacterial Load102000 ± 594000
SecondaryVentilated Associated Pneumonia

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

Time frame:
1 month
Reported as:
Count of participants · Participants
Ventilated Associated Pneumonia
ParticipantsEndotracheal UV Light
Ventilated Associated Pneumonia1
SecondaryDays to Extubation

Number of days patient is intubated with endotracheal tube or tracheostomy

Time frame:
1 month
Reported as:
Mean · days
Days to Extubation
daysEndotracheal UV Light
Days to Extubation20.75 (6 to 30)
SecondaryDays to Discharge

Number of days patient is discharged from the hospital

Time frame:
1 month
Reported as:
Mean · days
Days to Discharge
daysEndotracheal UV Light
Days to Discharge27.25 (19 to 30)
SecondaryChange in C-reactive Protein

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

Time frame:
5 days
Reported as:
Mean · mg/L
Change in C-reactive Protein
mg/LEndotracheal UV Light
Change in C-reactive Protein95.00 ± 48.00
SecondaryChange 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 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

Time frame:
1 month
Reported as:
Mean · Scores on a scale
Change in the World Health Organization (WHO) Coronavirus Disease (COVID)-19 10-point Ordinal Severity Scale by 30 Days
Scores on a scaleEndotracheal UV Light
Change in the World Health Organization (WHO) Coronavirus Disease (COVID)-19 10-point Ordinal Severity Scale by 30 Days3.6 (-1 to 7)
SecondaryCatheter Tip Assessment on the Last Day of Treatment

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

Time frame:
5 days

No measurements were reported for this outcome.

Adverse events

Collected over Up to 30 following enrollment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Endotracheal UV Light1/5 (20%)0/5 (0%)0/5 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Endotracheal UV Light
<=18 years0
Between 18 and 65 years4
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)Endotracheal UV Light
Female2
Male3
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Endotracheal UV Light
Hispanic or Latino3
Not Hispanic or Latino2
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Endotracheal UV Light
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White4
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Endotracheal UV Light
United States5
08

Study locations

1 site
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
09

References and documents

Publications

  • 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. PubMed 34173969 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 30, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04572399
Lead sponsor
Cedars-Sinai Medical Center
Collaborators
Aytu BioPharma, Inc.
Responsible party
George Chaux (Medical Director, Lung Transplant Program, Cedars-Sinai Medical Center) — Principal investigator
First posted
Oct 1, 2020
Start date
Oct 30, 2020
Primary completion
Dec 28, 2020
Completion
Dec 28, 2020
Results posted
Jan 18, 2022
Last update
Jan 9, 2025

Study contacts

George Chaux, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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