UVA Light Device to Treat COVID-19

Coronavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572399
• Other study ID #: 883
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: December 28, 2020

Study information

• Verified date: January 2022
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 28, 2020
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections

Intervention

Device:
• UV Light Treatment
UV light therapy administered while patient is mechanically ventilated

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Aytu BioPharma, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Viral Load	Change of viral load in upper airway in patients admitted to hospital for COVID-19	5 days
Secondary	Change in Bacterial Load	Change of bacterial load in upper airway	5 days
Secondary	Ventilated Associated Pneumonia	Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment	1 month
Secondary	Days to Extubation	Number of days patient is intubated with endotracheal tube or tracheostomy	1 month
Secondary	Days to Discharge	Number of days patient is discharged from the hospital	1 month
Secondary	Change in C-reactive Protein	Change in C-reactive protein from baseline to the end of the treatment	5 days
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; 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
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	5 days

External Links

•   Peer-reviewed publication