UVA Light Device to Treat COVID-19

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

Detailed Description
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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.

Official Title
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Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Pilot Study

Conditions
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Coronavirus

Intervention / Treatment
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* Device: UV Light Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endotracheal UV Light<br>Mechanically ventilated patients who will receive UV Light therapy | Device: UV Light Treatment<br>* UV light therapy administered while patient is mechanically ventilated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Viral Load | Change of viral load in upper airway in patients admitted to hospital for COVID-19 | 5 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 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 | 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 |