NCT04524715

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

July 31, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

August 19, 2020

Last Update Submit

July 13, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

  • Inflammation of the lungs - O2

    Change in inflammation of the lungs as measured by O2 saturation levels

    10 days

  • Inflammation of the lungs - CRP

    Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test

    10 days

  • Inflammation of the lungs - IL6

    Change in inflammation of the lungs as measured by IL-6 Levels

    10 days

Study Arms (2)

Active Treatment Group

EXPERIMENTAL

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.

Control Group

SHAM COMPARATOR

Treatment using a Sham comparator along with all standard treatment measures for COVID19.

Device: Sham Device Treatment

Interventions

Non-invasive red LLLT treatment to chest of patient.DEVICE

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.

Active Treatment Group
Sham Device TreatmentDEVICE

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.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is diagnosed with COVID-19.
  • Study participant is 18 years of age or older.
  • Patient exhibiting moderate-to-acute respiratory distress.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellness Junction

Millsboro, Delaware, 19966, United States

Location

Related Publications (8)

  • 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.

    PMID: 28748217BACKGROUND

  • Rigonato-Oliveira NC, de Brito AA, Vitoretti LB, de Cunha Moraes G, Goncalves 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.

    PMID: 31015955BACKGROUND

  • 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. No abstract available.

    PMID: 32291463BACKGROUND

  • de Lima FM, Villaverde AB, Albertini R, Correa JC, Carvalho RL, Munin E, Araujo 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.

    PMID: 21674546BACKGROUND

  • 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.

    PMID: 27621878BACKGROUND

  • Miranda da Silva C, Peres Leal M, Brochetti RA, Braga T, Vitoretti LB, Saraiva Camara 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.

    PMID: 26569396BACKGROUND

  • 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.

    PMID: 29686745BACKGROUND

  • Oliveira MC Jr, Greiffo FR, Rigonato-Oliveira NC, Custodio RW, Silva VR, Damaceno-Rodrigues NR, Almeida FM, Albertini R, Lopes-Martins RA, 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.

    PMID: 24792475BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rober H Burke, MD

    Michigan Center for Cosmetic Surgery

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 24, 2020

Study Start

July 31, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)