Coronavirus
Conditions
Brief summary
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.
Interventions
DEVICEUV Light Treatment
UV light therapy administered while patient is mechanically ventilated
Sponsors
Aytu BioPharma, Inc.
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intubated patients with confirmed SARS-CoV-2 will receive UV light treatment to potentially reduce bacterial and viral burden.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative Change in Viral Load | 5 days | Change of viral load in upper airway in patients admitted to hospital for COVID-19 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilated Associated Pneumonia | 1 month | Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment |
| Days to Extubation | 1 month | Number of days patient is intubated with endotracheal tube or tracheostomy |
| Days to Discharge | 1 month | Number of days patient is discharged from the hospital |
| Change in Bacterial Load | 5 days | Change of bacterial load in upper airway |
| Change in the World Health Organization (WHO) Coronavirus Disease (COVID)-19 10-point Ordinal Severity Scale by 30 Days | 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 |
| Catheter Tip Assessment on the Last Day of Treatment | 5 days | Assessment of total bacterial load on the UV catheter tip on the last day of treatment |
| Change in C-reactive Protein | 5 days | Change in C-reactive protein from baseline to the end of the treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endotracheal UV Light Mechanically ventilated patients who will receive UV Light therapy
UV Light Treatment: UV light therapy administered while patient is mechanically ventilated | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Endotracheal UV Light |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Negative Change in Viral Load
Change of viral load in upper airway in patients admitted to hospital for COVID-19
Time frame: 5 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Endotracheal UV Light | Negative Change in Viral Load | 3.2 log10 copies/mL |
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
Time frame: 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.
Secondary
Change in Bacterial Load
Change of bacterial load in upper airway
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endotracheal UV Light | Change in Bacterial Load | 102000 Colony forming units/mL | Standard Deviation 594000 |
Secondary
Change in C-reactive Protein
Change in C-reactive protein from baseline to the end of the treatment
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endotracheal UV Light | Change in C-reactive Protein | 95.00 mg/L | Standard Deviation 48 |
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 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Endotracheal UV Light | 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 |
Secondary
Days to Discharge
Number of days patient is discharged from the hospital
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Endotracheal UV Light | Days to Discharge | 27.25 days |
Secondary
Days to Extubation
Number of days patient is intubated with endotracheal tube or tracheostomy
Time frame: 1 month
Population: Mean days of intubation within the first 30 days of therapy. Deceased patient was not included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Endotracheal UV Light | Days to Extubation | 20.75 days |
Secondary
Ventilated Associated Pneumonia
Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment
Time frame: 1 month
Population: One case of probable ventilator associated pneumonia with purulent endotracheal secretions and positive endotracheal culture for Pseudomonas aeruginosa.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endotracheal UV Light | Ventilated Associated Pneumonia | 1 Participants |