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

August 3, 2020 updated by: Scott Sigman, MD, Lowell General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Lowell, Massachusetts, United States, 01854
        • Lowell General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Participants will receive MLS laser treatment along with regular inpatient medical care.
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.
Active Comparator: Control Group
Participants will receive regular inpatient medical care.
Other: Regular Inpatient Medical Care
Regular inpatient medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Disposition Post treatment
Time Frame: 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
7 days
oxygenation
Time Frame: 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
Daily for 4 days
IL-6 levels
Time Frame: First four days of trial
The change in pre treatment levels and 24 hours post final treatment
First four days of trial
Chest Xray radiographic results
Time Frame: 7 Days
Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale
7 Days
Brescia-COVID Respiratory Severity Scale
Time Frame: 7 days
The change in pretreatment and post treatment BCRSS will be evaluated
7 days
SMART-COP Score
Time Frame: 7 days
The change in pretreatment and post treatment scores will be evaluated
7 days
PSI Score
Time Frame: 7 days
The change in pretreatment and post treatment scores will be evaluated
7 days
CRP levels
Time Frame: 7 days
The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evalutated
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lowell General Hospital

Investigators

  • Principal Investigator: Scott Sigman, MD, Lowell General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2020

Primary Completion (Actual)

May 15, 2020

Study Completion (Actual)

July 16, 2020

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020.01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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