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

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Other: Regular Inpatient Medical Care; Device: MLS Laser

• Registration Number: NCT04391712
• Lead Sponsor: Lowell General Hospital

Brief Summary

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

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 Timeline

• Study Start: 2020-04-30
• Study First Submitted: 2020-05-04
• Primary Completion: 2020-05-15
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Study Completion: 2020-07-16
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Regular Inpatient Medical Care	Participants will receive regular inpatient medical care.
Experimental	MLS Laser	Participants will receive MLS laser treatment along with regular inpatient medical care.

Primary Outcome Measures

Name	Time	Method
oxygenation	Daily for 4 days	Patients oxygen requirements pulse oximetry will be evaluated for change from pre and post individual treatment as well as end of protocol
Chest Xray radiographic results	7 Days	Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale
PSI Score	7 days	The change in pretreatment and post treatment scores will be evaluated
CRP levels	7 days	The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evalutated
Brescia-COVID Respiratory Severity Scale	7 days	The change in pretreatment and post treatment BCRSS will be evaluated
IL-6 levels	First four days of trial	The change in pre treatment levels and 24 hours post final treatment
SMART-COP Score	7 days	The change in pretreatment and post treatment scores will be evaluated
Patient Disposition Post treatment	7 days	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

Trial Locations

Locations (1)

Lowell General Hospital; 🇺🇸 Lowell, Massachusetts, United States