LLLT Treatment of Lung Inflammation in COVID-19

July 13, 2022 updated by: Ward Photonics LLC

Low-Level Laser Therapy Treatment of Lung Inflammation in COVID-19 Patients

To determine if a reduction of pneumonic inflammation occurs after treatment with Low-Level Laser Therapy (LLLT) applying red-light technology in the respiratory system of COVID-19 patients suffering from acute viral pneumonia.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This clinical trial is a blinded before and after comparison of the effect on patients treated with a red-light LLLT therapy for acute lung inflammation as a result of COVID-19 infection. Patients are enrolled to undergo LLLT therapy in addition to all standard ongoing therapies for COVID-19.

Outcomes for patients receiving LLLT in addition to their standard care (the treatment group) are compared to the group receiving only standard therapy for COVID-19 (control group). Effects of LLLT treatment are measured immediately following treatment, and outcome measurements are compared to the pre-treatment baseline.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Millsboro, Delaware, United States, 19966
        • Wellness Junction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is diagnosed with COVID-19.
  • Study participant is 18 years of age or older.
  • Patient exhibiting moderate-to-acute respiratory distress.

Exclusion Criteria:

  • Photosensitive condition or medication.
  • Active chemotherapy treatment or other cancer treatment.
  • Autoimmune Disorder.
  • Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation.
  • Developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Treatment Group
LLLT Treatment using an UltraSlim red/IR LED device along with all standard treatment measures for COVID19.
Device: Non-invasive red LLLT treatment to chest of patient.
Expose patient to LLLT light while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively.
Sham Comparator: Control Group
Treatment using a Sham comparator along with all standard treatment measures for COVID19.
Device: Sham Device Treatment
Expose patient to sham device while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation of the lungs - O2
Time Frame: 10 days
Change in inflammation of the lungs as measured by O2 saturation levels
10 days
Inflammation of the lungs - CRP
Time Frame: 10 days
Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test
10 days
Inflammation of the lungs - IL6
Time Frame: 10 days
Change in inflammation of the lungs as measured by IL-6 Levels
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ward Photonics LLC

Investigators

  • Principal Investigator: Rober H Burke, MD, Michigan Center for Cosmetic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 31, 2021

Primary Completion (Anticipated)

March 31, 2022

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP19-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

This investigational study is exploratory in nature. The primary endpoint is most descriptive in statistical terms of whether the active patient group had significantly better outcomes than the control group. Individual patient data may be explored at a later date to determine related factors such as patient demographics, comorbidities, or other evidence of compounding variables.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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