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

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Ward Photonics LLC

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.

Condition or disease	Intervention/treatment	Phase
Covid19	Device: Non-invasive red LLLT treatment to chest of patient. Device: Sham Device Treatment	Not Applicable

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.

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019) Pneumonia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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

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.

Contacts and Locations

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): NCT04524715

Contacts

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Contact: Randal Horsley, DC	(302) 934-7350	drrlhorsley@gmail.com

Locations

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United States, Delaware
Wellness Junction
Millsboro, Delaware, United States, 19966
Contact: Randall Horsley, DC 302-934-7350 drrlhorsley@gmail.com

Sponsors and Collaborators

Ward Photonics LLC

Investigators

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Principal Investigator:	Rober H Burke, MD	Michigan Center for Cosmetic Surgery

More Information

Publications:

Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361. doi: 10.3934/biophy.2017.3.337. Epub 2017 May 19.

Rigonato-Oliveira NC, de Brito AA, Vitoretti LB, de Cunha Moraes G, Gonçalves T, Herculano KZ, Alves CE, Lino-Dos-Santos-Franco A, Aimbire F, Vieira RP, Ligeiro de Oliveira AP. Effect of Low-Level Laser Therapy (LLLT) in Pulmonary Inflammation in Asthma Induced by House Dust Mite (HDM): Dosimetry Study. Int J Inflam. 2019 Mar 21;2019:3945496. doi: 10.1155/2019/3945496. eCollection 2019.

Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14.

de Lima FM, Villaverde AB, Albertini R, Corrêa JC, Carvalho RL, Munin E, Araújo T, Silva JA, Aimbire F. Dual Effect of low-level laser therapy (LLLT) on the acute lung inflammation induced by intestinal ischemia and reperfusion: Action on anti- and pro-inflammatory cytokines. Lasers Surg Med. 2011 Jul;43(5):410-20. doi: 10.1002/lsm.21053.

Chen S, Li Y, Zheng Z, Luo Q, Chen R. The analysis of components that lead to increased work of breathing in chronic obstructive pulmonary disease patients. J Thorac Dis. 2016 Aug;8(8):2212-8. doi: 10.21037/jtd.2016.08.01.

Miranda da Silva C, Peres Leal M, Brochetti RA, Braga T, Vitoretti LB, Saraiva Câmara NO, Damazo AS, Ligeiro-de-Oliveira AP, Chavantes MC, Lino-Dos-Santos-Franco A. Low Level Laser Therapy Reduces the Development of Lung Inflammation Induced by Formaldehyde Exposure. PLoS One. 2015 Nov 16;10(11):e0142816. doi: 10.1371/journal.pone.0142816. eCollection 2015.

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 Júnior 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.

Oliveira MC Jr, Greiffo FR, Rigonato-Oliveira NC, Custódio RW, Silva VR, Damaceno-Rodrigues NR, Almeida FM, Albertini R, Lopes-Martins RÁ, de Oliveira LV, de Carvalho Pde T, Ligeiro de Oliveira AP, Leal EC Jr, Vieira RP. Low level laser therapy reduces acute lung inflammation in a model of pulmonary and extrapulmonary LPS-induced ARDS. J Photochem Photobiol B. 2014 May 5;134:57-63. doi: 10.1016/j.jphotobiol.2014.03.021. Epub 2014 Apr 4.

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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.

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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.:	No

Additional relevant MeSH terms:

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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

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