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

Lowell General Hospital10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19

Interventions

MLS LaserDEVICE

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.

Regular Inpatient Medical CareOTHER

Regular inpatient medical care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Lowell General Hospital

Lowell, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Daily for 4 days

IL-6 levels

The change in pre treatment levels and 24 hours post final treatment

Time frame: 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

Time frame: 7 Days

Brescia-COVID Respiratory Severity Scale

The change in pretreatment and post treatment BCRSS will be evaluated

Time frame: 7 days

SMART-COP Score

The change in pretreatment and post treatment scores will be evaluated

Time frame: 7 days

PSI Score

The change in pretreatment and post treatment scores will be evaluated

Time frame: 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

Time frame: 7 days

Data from ClinicalTrials.gov

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