LLLT Treatment of Lung Inflammation in COVID-19
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ClinicalTrials.gov Identifier: NCT04524715 |
Recruitment Status :
Not yet recruiting
First Posted : August 24, 2020
Last Update Posted : December 4, 2020
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Randomized |
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: | Single (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. |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Experimental: Active Treatment Group
LLLT Treatment using an UltraSlim red/IR LED device along with all standard treatment measures for COVID19.
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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.
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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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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) 934-7350 | drrlhorsley@gmail.com |
United States, Delaware | |
Wellness Junction | |
Millsboro, Delaware, United States, 19966 | |
Contact: Randall Horsley, DC 302-934-7350 drrlhorsley@gmail.com |
Principal Investigator: | Rober H Burke, MD | Michigan Center for Cosmetic Surgery |
Responsible Party: | Ward Photonics LLC |
ClinicalTrials.gov Identifier: | NCT04524715 |
Other Study ID Numbers: |
CP19-02 |
First Posted: | August 24, 2020 Key Record Dates |
Last Update Posted: | December 4, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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. |
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 |
COVID-19 Pneumonia Inflammation Respiratory Tract Infections Infections Pneumonia, Viral Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Pathologic Processes |