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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04391712
Recruitment Status : Completed
First Posted : May 18, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Scott Sigman, MD, Lowell General Hospital

Tracking Information
First Submitted Date  ICMJE May 4, 2020
First Posted Date  ICMJE May 18, 2020
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE April 30, 2020
Actual Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • 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
  • 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
  • IL-6 levels [ Time Frame: First four days of trial ]
    The change in pre treatment levels and 24 hours post final treatment
  • Chest Xray radiographic results [ Time Frame: 7 Days ]
    Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale
  • Brescia-COVID Respiratory Severity Scale [ Time Frame: 7 days ]
    The change in pretreatment and post treatment BCRSS will be evaluated
  • SMART-COP Score [ Time Frame: 7 days ]
    The change in pretreatment and post treatment scores will be evaluated
  • PSI Score [ Time Frame: 7 days ]
    The change in pretreatment and post treatment scores will be evaluated
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2020)
  • Patient Disposition Post treatment [ Time Frame: 7 days ]
    ICU on vent, ICU not requiring ventilation, Discharge to Rehab requiring assitance, Discharge to Home unable to perform ADL's, Discharge to Home able to perform ADL's
  • 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
  • IL-6 levels [ Time Frame: First four days of trial ]
    The change in pre treatment levels and 24 hours post final treatment
  • Chest Xray radiographic results [ Time Frame: 7 Days ]
    Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale
  • Brescia-COVID Respiratory Severity Scale [ Time Frame: 7 days ]
    The change in pretreatment and postreatment BCRSS will be evaluated
  • SMART-COP Score [ Time Frame: 7 days ]
    The change in pretreatment and post treatment scores will be evaluated
  • PSI Score [ Time Frame: 7 days ]
    The change in pretreatment and post treatment scores will be evalutated
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
Official Title  ICMJE Multiwave Locked System (MLS) Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study will utilize a randomized parallel assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Experimental
    Participants will receive MLS laser treatment along with regular inpatient medical care.
    Intervention: Device: MLS Laser
  • Active Comparator: Control Group
    Participants will receive regular inpatient medical care.
    Intervention: Other: Regular Inpatient Medical Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2020)
10
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2020)
20
Actual Study Completion Date  ICMJE July 16, 2020
Actual Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04391712
Other Study ID Numbers  ICMJE 2020.01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott Sigman, MD, Lowell General Hospital
Study Sponsor  ICMJE Lowell General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott Sigman, MD Lowell General Hospital
PRS Account Lowell General Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP