UVA Light Device to Treat COVID-19

NCT ID: NCT04572399

Last Updated: 2025-01-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2020-12-28

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.

Conditions

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Coronavirus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intubated patients with confirmed SARS-CoV-2 will receive UV light treatment to potentially reduce bacterial and viral burden.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endotracheal UV Light

Mechanically ventilated patients who will receive UV Light therapy

Group Type EXPERIMENTAL

UV Light Treatment

Intervention Type DEVICE

UV light therapy administered while patient is mechanically ventilated

Interventions

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UV Light Treatment

UV light therapy administered while patient is mechanically ventilated

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aytu BioPharma, Inc.

INDUSTRY

Sponsor Role collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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George Chaux

Medical Director, Lung Transplant Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George Chaux, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 34173969 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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883

Identifier Type: -

Identifier Source: org_study_id

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