Back to resultsLLLT Treatment of Lung Inflammation in COVID-19
Primary Purpose
Covid19
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-invasive red LLLT treatment to chest of patient.
Sham Device Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Participant is diagnosed with COVID-19.
- Study participant is 18 years of age or older.
- Patient exhibiting moderate-to-acute respiratory distress.
Exclusion Criteria:
- Photosensitive condition or medication.
- Active chemotherapy treatment or other cancer treatment.
- Autoimmune Disorder.
- Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation.
- Developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
Sites / Locations
- Wellness Junction
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active Treatment Group
Control Group
Arm Description
LLLT Treatment using an UltraSlim red/IR LED device along with all standard treatment measures for COVID19.
Treatment using a Sham comparator along with all standard treatment measures for COVID19.
Outcomes
Primary Outcome Measures
Inflammation of the lungs - O2
Change in inflammation of the lungs as measured by O2 saturation levels
Inflammation of the lungs - CRP
Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test
Inflammation of the lungs - IL6
Change in inflammation of the lungs as measured by IL-6 Levels
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04524715
Brief Title
LLLT Treatment of Lung Inflammation in COVID-19
Official Title
Low-Level Laser Therapy Treatment of Lung Inflammation in COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Based upon feedback from IRB.
Study Start Date
July 31, 2021 (Anticipated)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ward Photonics LLC
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if a reduction of pneumonic inflammation occurs after treatment with Low-Level Laser Therapy (LLLT) applying red-light technology in the respiratory system of COVID-19 patients suffering from acute viral pneumonia.
Detailed Description
This clinical trial is a blinded before and after comparison of the effect on patients treated with a red-light LLLT therapy for acute lung inflammation as a result of COVID-19 infection. Patients are enrolled to undergo LLLT therapy in addition to all standard ongoing therapies for COVID-19.
Outcomes for patients receiving LLLT in addition to their standard care (the treatment group) are compared to the group receiving only standard therapy for COVID-19 (control group). Effects of LLLT treatment are measured immediately following treatment, and outcome measurements are compared to the pre-treatment baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Blinded before and after comparison of COVID-19 patients treated with a red-light LLLT therapy in addition to standard treatment measures compared to a control group receiving only standard treatment measures.
Masking
Participant
Masking Description
All participants undergo LLLT treatment; however, the active group receives LED light in the red and IR range while the placebo group is told they are receiving IR light not visible to naked eye. All participants continue receiving standard treatments for COVID19 symptoms.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment Group
Arm Type
Experimental
Arm Description
LLLT Treatment using an UltraSlim red/IR LED device along with all standard treatment measures for COVID19.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Treatment using a Sham comparator along with all standard treatment measures for COVID19.
Intervention Type
Device
Intervention Name(s)
Non-invasive red LLLT treatment to chest of patient.
Intervention Description
Expose patient to LLLT light while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively.
Intervention Type
Device
Intervention Name(s)
Sham Device Treatment
Intervention Description
Expose patient to sham device while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively.
Primary Outcome Measure Information:
Title
Inflammation of the lungs - O2
Description
Change in inflammation of the lungs as measured by O2 saturation levels
Time Frame
10 days
Title
Inflammation of the lungs - CRP
Description
Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test
Time Frame
10 days
Title
Inflammation of the lungs - IL6
Description
Change in inflammation of the lungs as measured by IL-6 Levels
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant is diagnosed with COVID-19.
Study participant is 18 years of age or older.
Patient exhibiting moderate-to-acute respiratory distress.
Exclusion Criteria:
Photosensitive condition or medication.
Active chemotherapy treatment or other cancer treatment.
Autoimmune Disorder.
Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation.
Developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rober H Burke, MD
Organizational Affiliation
Michigan Center for Cosmetic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellness Junction
City
Millsboro
State/Province
Delaware
ZIP/Postal Code
19966
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This investigational study is exploratory in nature. The primary endpoint is most descriptive in statistical terms of whether the active patient group had significantly better outcomes than the control group. Individual patient data may be explored at a later date to determine related factors such as patient demographics, comorbidities, or other evidence of compounding variables.
Citations:
PubMed Identifier
28748217
Citation
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Results Reference
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PubMed Identifier
31015955
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
21674546
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
da Cunha Moraes G, Vitoretti LB, de Brito AA, Alves CE, de Oliveira NCR, Dos Santos Dias A, Matos YST, Oliveira-Junior MC, Oliveira LVF, da Palma RK, Candeo LC, Lino-Dos-Santos-Franco A, Horliana ACRT, Gimenes Junior JA, Aimbire F, Vieira RP, Ligeiro-de-Oliveira AP. Low-Level Laser Therapy Reduces Lung Inflammation in an Experimental Model of Chronic Obstructive Pulmonary Disease Involving P2X7 Receptor. Oxid Med Cell Longev. 2018 Mar 4;2018:6798238. doi: 10.1155/2018/6798238. eCollection 2018.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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LLLT Treatment of Lung Inflammation in COVID-19
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