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Completed

NCT Number: NCT04572399

UVA Light Device to Treat COVID-19

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

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Key information

Conditions

Coronavirus Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UV Light Treatment

Device

UV light therapy administered while patient is mechanically ventilated

Primary outcomes

  1. Negative Change in Viral Load

    Time frame: 5 days

    Change of viral load in upper airway in patients admitted to hospital for COVID-19

Secondary outcomes

  1. Change in Bacterial Load

    Time frame: 5 days

    Change of bacterial load in upper airway

  2. Ventilated Associated Pneumonia

    Time frame: 1 month

    Percentage of patients developing ventilated pneumonia (VAP) within 30 days of treatment

  3. Days to Extubation

    Time frame: 1 month

    Number of days patient is intubated with endotracheal tube or tracheostomy

  4. Days to Discharge

    Time frame: 1 month

    Number of days patient is discharged from the hospital

  5. Change in C-reactive Protein

    Time frame: 5 days

    Change in C-reactive protein from baseline to the end of the treatment

  6. Change in the World Health Organization (WHO) Coronavirus Disease (COVID)-19 10-point Ordinal Severity Scale by 30 Days

    Time frame: 1 month

    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

  7. Catheter Tip Assessment on the Last Day of Treatment

    Time frame: 5 days

    Assessment of total bacterial load on the UV catheter tip on the last day of treatment

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • Aytu BioPharma, Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2020
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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