LLLT Treatment of Lung Inflammation in COVID-19
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04524715|
Recruitment Status : Not yet recruiting
First Posted : August 24, 2020
Last Update Posted : December 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Device: Non-invasive red LLLT treatment to chest of patient. Device: Sham Device Treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 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.|
|Official Title:||Low-Level Laser Therapy Treatment of Lung Inflammation in COVID-19 Patients|
|Estimated Study Start Date :||March 31, 2021|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: Active Treatment Group
LLLT Treatment using an UltraSlim red/IR LED device along with all standard treatment measures for COVID19.
Device: Non-invasive red LLLT treatment to chest of patient.
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.
Sham Comparator: Control Group
Treatment using a Sham comparator along with all standard treatment measures for COVID19.
Device: Sham Device Treatment
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.
- Inflammation of the lungs - O2 [ Time Frame: 10 days ]Change in inflammation of the lungs as measured by O2 saturation levels
- Inflammation of the lungs - CRP [ Time Frame: 10 days ]Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test
- Inflammation of the lungs - IL6 [ Time Frame: 10 days ]Change in inflammation of the lungs as measured by IL-6 Levels
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): NCT04524715
|Contact: Randal Horsley, DC||(302) email@example.com|
|United States, Delaware|
|Millsboro, Delaware, United States, 19966|
|Contact: Randall Horsley, DC 302-934-7350 firstname.lastname@example.org|
|Principal Investigator:||Rober H Burke, MD||Michigan Center for Cosmetic Surgery|