Back to resultsPhotobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MLS Laser
Regular Inpatient Medical Care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID, Laser, Pulmonary
Eligibility Criteria
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
Sites / Locations
- Lowell General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control Group
Arm Description
Participants will receive MLS laser treatment along with regular inpatient medical care.
Participants will receive regular inpatient medical care.
Outcomes
Primary Outcome Measures
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
oxygenation
Patients oxygen requirements pulse oximetry will be evaluated for change from pre and post individual treatment as well as end of protocol
IL-6 levels
The change in pre treatment levels and 24 hours post final treatment
Chest Xray radiographic results
Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale
Brescia-COVID Respiratory Severity Scale
The change in pretreatment and post treatment BCRSS will be evaluated
SMART-COP Score
The change in pretreatment and post treatment scores will be evaluated
PSI Score
The change in pretreatment and post treatment scores will be evaluated
CRP levels
The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evalutated
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04391712
Brief Title
Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
Official Title
Multiwave Locked System (MLS) Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
July 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lowell General Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID, Laser, Pulmonary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This study will utilize a randomized parallel assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Participants will receive MLS laser treatment along with regular inpatient medical care.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants will receive regular inpatient medical care.
Intervention Type
Device
Intervention Name(s)
MLS Laser
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Regular Inpatient Medical Care
Intervention Description
Regular inpatient medical care
Primary Outcome Measure Information:
Title
Patient Disposition Post treatment
Description
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
Title
oxygenation
Description
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
Title
IL-6 levels
Description
The change in pre treatment levels and 24 hours post final treatment
Time Frame
First four days of trial
Title
Chest Xray radiographic results
Description
Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale
Time Frame
7 Days
Title
Brescia-COVID Respiratory Severity Scale
Description
The change in pretreatment and post treatment BCRSS will be evaluated
Time Frame
7 days
Title
SMART-COP Score
Description
The change in pretreatment and post treatment scores will be evaluated
Time Frame
7 days
Title
PSI Score
Description
The change in pretreatment and post treatment scores will be evaluated
Time Frame
7 days
Title
CRP levels
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Sigman, MD
Organizational Affiliation
Lowell General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lowell General Hospital
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
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