Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With COVID-19

NCT04386694 | Completed FDA Device

• 1 other identifier: 3.985.226
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 (COVID-19) is a disease caused by a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). The most characteristic symptom of patients with COVID-19 is respiratory distress, leading to inability to sustain spontaneous breathing. In addition, patients with COVID-19 have dyspnea and respiratory muscle fatigue. Therefore, it is necessary to use strategies that minimize the impact of COVID-19 on the respiratory muscles, accelerating the ventilatory weaning process and optimizing the functional capacity of the involved muscles. Over the past years, evidence has shown the effectivity of photobiomodulation therapy (PBMT) combined with static magnetic field (sMF) (PBMT/sMF) in delaying muscle fatigue, decrease in markers of inflammatory damage and oxidative stress of skeletal muscle. These effects result in an improvement in the functional capacity of the irradiated muscles by PBMT/sMF. However, do date, there is a lack of evidence regarding the effects of PBMT/sMF on the respiratory muscles. Therefore, the irradiation of PBMT/sMF may result in improvement in the functional capacity of respiratory muscles in patients with COVID-19, accelerating the ventilatory weaning process of the patients intubated due to respiratory failure. In addition, the irradiation of PBMT/sMF may induce the increase of anti-inflammatory mediators' activity in patients with COVID-19. Thus, the aim of this project is to investigate the effects of PBMT/sMF on respiratory muscles of patients admitted to the Intensive Care Unit (ICU) with COVID-19 using invasive mechanical ventilation.

Conditions

COVID-19; Respiratory Failure

Keywords

Photobiomodulation Therapy; Static Magnetic Fields; Low-Level Laser Therapy; COVID-19; Invasive Mechanical Ventilation; Respiratory Muscles; Intensive Care United

Outcome Measures

Primary Outcomes (1)

• Time until discharge

  Number of days hospitalized in the ICU until discharge or death.

  From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days.

Secondary Outcomes (15)

• Survival rate

  From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days.

• Diaphragm muscle function

  10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

• Platelet count

  10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

• Leukogram

  10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

• Erythrogram

  10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

Study Arms (2)

PBMT/sMF

EXPERIMENTAL

Active PBMT/sMF will be applied once a day, during the ICU stay, until discharge or death. The patients will receive standard physical therapy care associated with PBMT/sMF. PBMT/sMF will be applied using MR5™ ACTIV PRO LaserShower, manufactured by Multi Radiance Medical (Solon, OH, USA). This device has 4 diodes of 905 nm (1.25 mW each diode, 0.32 cm2 each), 8 diodes of 633 nm (25 mW each diode, 0.85 cm2 - each), and 8 diodes of 850 nm (40 mW each diode, 0.56 cm2 - each). The static magnetic field is 110 mT.

Device: Active PBMT/sMF

Placebo PBMT/sMF

PLACEBO COMPARATOR

Placebo PBMT/sMF will be applied once a day, during the ICU stay, until discharge or death. The patients will receive standard physical therapy care associated with placebo PBMT/sMF. The placebo PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA). The ACTIV PRO emits 905nm, and 850nm via an electric diode energy source with outputs to 0%. The static magnetic field will be also turned off. The 660nm light via an electric diode energy source with outputs to \>1% to appear like the active comparator.

Device: Placebo PBMT/sMF

Interventions

Active PBMT/sMF DEVICE

The PBMT/sMF will be irradiated in the lower thorax and neck areas, with the patients in supine position. PBMT/sMF application time will be 60 seconds per site. The dose used in the lower thorax will be 31.50 J per site, a total of 6 sites will be irradiated, totalizing a dose of 189J. In addition, the dose used in the neck area (bilaterally) will be 31.50J per site, a total of 1 site (bilaterally) will be irradiated, totalizing a dose of 31.50J (bilaterally). PBMT/sMF will be applied using the direct contact method with light pressure on the skin.

PBMT/sMF

Placebo PBMT/sMF DEVICE

The placebo PBMT/sMF will be irradiated in the lower thorax and neck areas, with the patients in supine position. PBMT/sMF application time will be 60 seconds per site. The dose used for applications during the treatment will be 0 Joules (J) per site. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). PBMT/sMF will be applied using the direct contact method with light pressure on the skin.

Placebo PBMT/sMF

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the adult Intensive Care Unit with Covid-19 infection;
• Need for orotracheal intubation;
• Invasive mechanical ventilation due to respiratory failure.

You may not qualify if:

• Suspected patients who had a negative result of the diagnostic examination for COVID-19 infection;
• Patients positioned in pronation for more than 24 hours;
• Cancer patients;
• Pregnancy.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Hospital Tacchini/RS: collaborator

Study Sites (1)

Hospital Tacchini

Bento Gonçalves, Rio Grande do Sul, 95700-068, Brazil

Location

Related Publications (1)

• De Marchi T, Francio F, Ferlito JV, Weigert R, de Oliveira C, Merlo AP, Pandini DL, Pasqual-Junior BA, Giovanella D, Tomazoni SS, Leal-Junior EC. Effects of Photobiomodulation Therapy Combined with Static Magnetic Field in Severe COVID-19 Patients Requiring Intubation: A Pragmatic Randomized Placebo-Controlled Trial. J Inflamm Res. 2021 Jul 24;14:3569-3585. doi: 10.2147/JIR.S318758. eCollection 2021.

  PMID: 34335043 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A researcher will program the device (PMBT/sMF or placebo) and will be instructed not to inform the patients or other researchers as to the type of treatment (PMBT/sMF or placebo). Therefore, the therapist responsible for the treatment, the investigators and the outcome assessors will be blinded to the type of treatment being administered to the patients. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (PBMT/sMF or placebo).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: May 18, 2020
• Primary Completion: September 17, 2020
• Study Completion: September 17, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

BR (1)