CoronavirusNCT04572399
UVA Light Device to Treat COVID-19
A study testing UV Light Treatment in people with Coronavirus, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This pilot study will assess the safety and effectiveness of UV light treatment in hospitalized patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus
- What is being tested?
- UV Light Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 28 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed positive test result for SARS-CoV-2
- Mechanically ventilated
- Endotracheal tube inner diameter of at least 7.5 mm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Pilot Study
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.
- Conditions
- Coronavirus
- Being tested
- UV Light Treatment
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV Light TreatmentDevice
UV light therapy administered while patient is mechanically ventilated
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal UV Light | Experimental | Mechanically ventilated patients who will receive UV Light therapy Receives: Device: UV Light Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Change in Viral Load
Change of viral load in upper airway in patients admitted to hospital for COVID-19
Measured: 5 days
Secondary outcomes (7)
Change in Bacterial Load
Change of bacterial load in upper airway
Measured: 5 days
Ventilated Associated Pneumonia
Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment
Measured: 1 month
Days to Extubation
Number of days patient is intubated with endotracheal tube or tracheostomy
Measured: 1 month
Days to Discharge
Number of days patient is discharged from the hospital
Measured: 1 month
Change in C-reactive Protein
Change in C-reactive protein from baseline to the end of the treatment
Measured: 5 days
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
- 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
Measured: 1 month
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
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start30 Oct 2020
- Primary completion28 Dec 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aytu BioPharma, Inc.
- Responsible party
- Principal investigator, George Chaux, Cedars-Sinai Medical Center
- Investigators
- George Chaux, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572399
- Sponsor's protocol ID
- 883
- Status last verified
- Dec 2024
- First submitted
- 28 Sep 2020
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Pilot Study
- ClinicalTrials.gov ID
- NCT04572399
- Acronym / sponsor ID
- 883
- Conditions
- Coronavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Aytu BioPharma, Inc.
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Posted 18 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intubated patients with confirmed SARS-CoV-2 will receive UV light treatment to potentially reduce bacterial and viral burden.
| Arm | Type | Receives |
|---|---|---|
| Endotracheal UV Light | Experimental | Device: UV Light TreatmentMechanically ventilated patients who will receive UV Light therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed positive test result for SARS-CoV-2
- Mechanically ventilated
- Endotracheal tube inner diameter of at least 7.5 mm
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UV Light TreatmentUV light therapy administered while patient is mechanically ventilated | Device | Endotracheal UV Light |
Primary outcome
Negative Change in Viral Load
Time frame: 5 days
Change of viral load in upper airway in patients admitted to hospital for COVID-19
7 secondary outcomes
Change in Bacterial Load
Time frame: 5 days
Ventilated Associated Pneumonia
Time frame: 1 month
Days to Extubation
Time frame: 1 month
Days to Discharge
Time frame: 1 month
Change in C-reactive Protein
Time frame: 5 days
Change in the World Health Organization (WHO) Coronavirus Disease (COVID)-19 10-point Ordinal Severity Scale by 30 Days
Time frame: 1 month
Catheter Tip Assessment on the Last Day of Treatment
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34173969Rezaie 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.
- Peer-reviewed publicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Chaux, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UV Light Treatment in people with Coronavirus, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative Change in Viral Load (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04572399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.