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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Device: MLS Laser Other: Regular Inpatient Medical Care Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will utilize a randomized parallel assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiwave Locked System (MLS) Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
Actual Study Start Date : April 30, 2020
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : July 16, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. IL-6 levels [ Time Frame: First four days of trial ]
    The change in pre treatment levels and 24 hours post final treatment

  4. Chest Xray radiographic results [ Time Frame: 7 Days ]
    Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale

  5. Brescia-COVID Respiratory Severity Scale [ Time Frame: 7 days ]
    The change in pretreatment and post treatment BCRSS will be evaluated

  6. SMART-COP Score [ Time Frame: 7 days ]
    The change in pretreatment and post treatment scores will be evaluated

  7. PSI Score [ Time Frame: 7 days ]
    The change in pretreatment and post treatment scores will be evaluated

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391712


Locations
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United States, Massachusetts
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
Sponsors and Collaborators
Lowell General Hospital
Investigators
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Principal Investigator: Scott Sigman, MD Lowell General Hospital
More Information
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Responsible Party: Scott Sigman, MD, Principal Investigator, Lowell General Hospital
ClinicalTrials.gov Identifier: NCT04391712    
Other Study ID Numbers: 2020.01
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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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
Keywords provided by Scott Sigman, MD, Lowell General Hospital:
COVID
Laser
Pulmonary
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases