UVA Light Device to Treat COVID-19
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ClinicalTrials.gov Identifier: NCT04572399 |
Recruitment Status :
Completed
First Posted : October 1, 2020
Results First Posted : January 18, 2022
Last Update Posted : January 18, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronavirus | Device: UV Light Treatment | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Endotracheal UV Light
Mechanically ventilated patients who will receive UV Light therapy
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Device: UV Light Treatment
UV light therapy administered while patient is mechanically ventilated |
- Change in Viral Load [ Time Frame: 5 days ]Change of viral load in upper airway in patients admitted to hospital for COVID-19
- 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) within 30 days of treatment
- Days to Extubation [ Time Frame: 1 month ]Number of days patient is intubated with endotracheal tube or tracheostomy
- Days to Discharge [ Time Frame: 1 month ]Number of days patient is discharged from the hospital
- Change in C-reactive Protein [ Time Frame: 5 days ]Change in C-reactive protein from baseline to the end of the treatment
- 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
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 |
Principal Investigator: | George Chaux, MD | Cedars-Sinai Medical Center |
Documents provided by George Chaux, Cedars-Sinai Medical Center:
Publications of Results:
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 |
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 |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Virus Diseases Infections |