LLLT Treatment of Lung Inflammation in COVID-19

Covid19 Clinical Trial

Official title:

Low-Level Laser Therapy Treatment of Lung Inflammation in COVID-19 Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04524715
• Other study ID #: CP19-02
• Status: Withdrawn
• Phase: N/A
• Start date: July 31, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2022
• Source: Ward Photonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Inflammation
• Pneumonia

Intervention

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 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.

Locations

Country	Name	City	State
United States	Wellness Junction	Millsboro	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Ward Photonics LLC

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation of the lungs - O2	Change in inflammation of the lungs as measured by O2 saturation levels	10 days
Primary	Inflammation of the lungs - CRP	Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test	10 days
Primary	Inflammation of the lungs - IL6	Change in inflammation of the lungs as measured by IL-6 Levels	10 days