Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection.

Detailed Description
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Participants will be randomized into treatment vs. control group. Both groups will receive regular inpatient medical treatment. Participants in the experimental arm will receive laser treatments once daily for 4 days. Treatments will be delivered to the patients in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz. Standard nursing protocols would be used to identify participant's pulmonary status throughout treatment.

Official Title
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Multiwave Locked System (MLS) Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease

Conditions
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COVID-19

Intervention / Treatment
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* Device: MLS Laser
* Other: Regular Inpatient Medical Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID-19 positive Pulmonary compromise requiring oxygen support of approximately 2-6 liters Able to self prone, or support in self-sitting position Exclusion Criteria: Ventilator management Patients with autoimmune disorders or inflammatory conditions not related to COVID-19 Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: This study will utilize a randomized parallel assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Participants will receive MLS laser treatment along with regular inpatient medical care. | Device: MLS Laser<br>* Treatments will be delivered to the participants days 1-4, in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz.<br>|
| Active Comparator: Control Group<br>Participants will receive regular inpatient medical care. | Other: Regular Inpatient Medical Care<br>* Regular inpatient medical care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Disposition Post treatment | ICU on vent, ICU not requiring ventilation, Discharge to Rehab requiring assistance, Discharge to Home unable to perform ADL's, Discharge to Home able to perform ADL's | 7 days | 
| oxygenation | Patients oxygen requirements pulse oximetry will be evaluated for change from pre and post individual treatment as well as end of protocol | Daily for 4 days | 
| IL-6 levels | The change in pre treatment levels and 24 hours post final treatment | First four days of trial | 
| Chest Xray radiographic results | Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale | 7 Days | 
| Brescia-COVID Respiratory Severity Scale | The change in pretreatment and post treatment BCRSS will be evaluated | 7 days | 
| SMART-COP Score | The change in pretreatment and post treatment scores will be evaluated | 7 days | 
| PSI Score | The change in pretreatment and post treatment scores will be evaluated | 7 days | 
| CRP levels | The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evalutated | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser, COVID, Pulmonary