UVA Light Device to Treat COVID-19

Not Applicable

Completed

• Conditions: Coronavirus

• Registration Number: NCT04572399
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-01
• Study Start: 2020-10-30
• Primary Completion: 2020-12-28
• Study Completion: 2020-12-28
• Results First Submitted: 2021-09-22
• Results First Submitted QC: 2022-01-13
• Results First Posted: 2022-01-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Negative Change in Viral Load	5 days	Change of viral load in upper airway in patients admitted to hospital for COVID-19

Secondary Outcome Measures

Name	Time	Method
Change in Bacterial Load	5 days	Change of bacterial load in upper airway
Ventilated Associated Pneumonia	1 month	Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment
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
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 C-reactive Protein	5 days	Change in C-reactive protein from baseline to the end of the treatment
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

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States