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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391712
• Other study ID #: 2020.01
• Status: Completed
• Phase: Phase 2
• Start date: April 30, 2020
• Est. completion date: July 16, 2020

Study information

• Verified date: August 2020
• Source: Lowell General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 16, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Lung Diseases

Intervention

Device:
• MLS Laser
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.

Other:
• Regular Inpatient Medical Care
Regular inpatient medical care

Locations

Country	Name	City	State
United States	Lowell General Hospital	Lowell	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lowell General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	IL-6 levels	The change in pre treatment levels and 24 hours post final treatment	First four days of trial
Primary	Chest Xray radiographic results	Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale	7 Days
Primary	Brescia-COVID Respiratory Severity Scale	The change in pretreatment and post treatment BCRSS will be evaluated	7 days
Primary	SMART-COP Score	The change in pretreatment and post treatment scores will be evaluated	7 days
Primary	PSI Score	The change in pretreatment and post treatment scores will be evaluated	7 days
Primary	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