NCT04572399

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 18, 2022

Completed
Last Updated

January 9, 2025

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

September 28, 2020

Results QC Date

September 22, 2021

Last Update Submit

December 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Negative Change in Viral Load

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

    5 days

Secondary Outcomes (7)

  • Change in Bacterial Load

    5 days

  • Ventilated Associated Pneumonia

    1 month

  • Days to Extubation

    1 month

  • Days to Discharge

    1 month

  • Change in C-reactive Protein

    5 days

  • +2 more secondary outcomes

Study Arms (1)

Endotracheal UV Light

EXPERIMENTAL

Mechanically ventilated patients who will receive UV Light therapy

Device: UV Light Treatment

Interventions

UV light therapy administered while patient is mechanically ventilated

Endotracheal UV Light

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed positive test result for SARS-CoV-2
  • Mechanically ventilated
  • Endotracheal tube inner diameter of at least 7.5 mm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related 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. Adv Ther. 2021 Aug;38(8):4556-4568. doi: 10.1007/s12325-021-01830-7. Epub 2021 Jun 26.

Related Links

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Results Point of Contact

Title
Melissa Hampton
Organization
Cedars-Sinai

Study Officials

  • George Chaux, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Intubated patients with confirmed SARS-CoV-2 will receive UV light treatment to potentially reduce bacterial and viral burden.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Lung Transplant Program

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 1, 2020

Study Start

October 30, 2020

Primary Completion

December 28, 2020

Study Completion

December 28, 2020

Last Updated

January 9, 2025

Results First Posted

January 18, 2022

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations