LLLT Treatment of Lung Inflammation in COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Device: Non-invasive red LLLT treatment to chest of patient.
* Device: Sham Device Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Blinded before and after comparison of COVID-19 patients treated with a red-light LLLT therapy in addition to standard treatment measures compared to a control group receiving only standard treatment measures.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment Group<br>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.<br>* 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.<br>|
| Sham Comparator: Control Group<br>Treatment using a Sham comparator along with all standard treatment measures for COVID19. | Device: Sham Device Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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