Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
Multiwave Locked System (MLS) Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 covid19
Started Apr 2020
Shorter than P25 for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2020
CompletedFirst Submitted
Initial submission to the registry
May 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2020
CompletedAugust 5, 2020
August 1, 2020
15 days
May 4, 2020
August 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
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
IL-6 levels
The change in pre treatment levels and 24 hours post final treatment
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
7 Days
Brescia-COVID Respiratory Severity Scale
The change in pretreatment and post treatment BCRSS will be evaluated
7 days
SMART-COP Score
The change in pretreatment and post treatment scores will be evaluated
7 days
PSI Score
The change in pretreatment and post treatment scores will be evaluated
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
7 days
Study Arms (2)
Experimental
EXPERIMENTALParticipants will receive MLS laser treatment along with regular inpatient medical care.
Control Group
ACTIVE COMPARATORParticipants will receive regular inpatient medical care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- COVID-19 positive
- Pulmonary compromise requiring oxygen support of approximately 2-6 liters
- Able to self prone, or support in self-sitting position
You may not qualify if:
- Ventilator management
- Patients with autoimmune disorders or inflammatory conditions not related to COVID-19
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Sigman, MD
Lowell General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 18, 2020
Study Start
April 30, 2020
Primary Completion
May 15, 2020
Study Completion
July 16, 2020
Last Updated
August 5, 2020
Record last verified: 2020-08