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| Name | Class |
|---|---|
| Aytu BioPharma, Inc. | INDUSTRY |
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This pilot study will assess the safety and effectiveness of UV light treatment in hospitalized patients with COVID-19.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endotracheal UV Light | Experimental | Mechanically ventilated patients who will receive UV Light therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UV Light Treatment | Device | UV light therapy administered while patient is mechanically ventilated |
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| Measure | Description | Time Frame |
|---|---|---|
| Negative Change in Viral Load | Change of viral load in upper airway in patients admitted to hospital for COVID-19 | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bacterial Load | Change of bacterial load in upper airway | 5 days |
| Ventilated Associated Pneumonia | Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Chaux, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34173969 | Result | 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. |
| Label | URL |
|---|---|
| Peer-reviewed publication | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endotracheal UV Light | Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endotracheal UV Light | Mechanically ventilated patients who will receive UV Light therapy UV Light Treatment: UV light therapy administered while patient is mechanically ventilated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Negative Change in Viral Load | Change of viral load in upper airway in patients admitted to hospital for COVID-19 | Posted | Mean | Full Range | log10 copies/mL | 5 days |
|
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Up to 30 following enrollment.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endotracheal UV Light | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Hampton | Cedars-Sinai | 3104230617 | Melissa.Hampton@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2020 | Jan 11, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Intubated patients with confirmed SARS-CoV-2 will receive UV light treatment to potentially reduce bacterial and viral burden.
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| 1 month |
| Days to Extubation | Number of days patient is intubated with endotracheal tube or tracheostomy | 1 month |
| Days to Discharge | Number of days patient is discharged from the hospital | 1 month |
| Change in C-reactive Protein | Change in C-reactive protein from baseline to the end of the treatment | 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
| 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 | 5 days |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Change in Bacterial Load | Change of bacterial load in upper airway | Posted | Mean | Standard Deviation | Colony forming units/mL | 5 days |
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| Secondary | Ventilated Associated Pneumonia | Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment | One case of probable ventilator associated pneumonia with purulent endotracheal secretions and positive endotracheal culture for Pseudomonas aeruginosa. | Posted | Count of Participants | Participants | 1 month |
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|
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| Secondary | Days to Extubation | Number of days patient is intubated with endotracheal tube or tracheostomy | Mean days of intubation within the first 30 days of therapy. Deceased patient was not included. | Posted | Mean | Full Range | days | 1 month |
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|
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| Secondary | Days to Discharge | Number of days patient is discharged from the hospital | Mean number days for the patients to be discharged from the hospital within the first 30 days. Deceased patient was not included. | Posted | Mean | Full Range | days | 1 month |
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|
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| Secondary | Change in C-reactive Protein | Change in C-reactive protein from baseline to the end of the treatment | Posted | Mean | Standard Deviation | mg/L | 5 days |
|
|
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| Secondary | 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
| Posted | Mean | Full Range | Scores on a scale | 1 month |
|
|
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| Secondary | 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 | Catheter tips could not be retrieved in a sterile fashion due to infectious disease protocols in ICU. Therefore, data were not collected. | Posted | 5 days |
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| 1 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D007239 |
| Infections |