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

Primary Purpose

COVID-19, Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active PBMT/sMF
Placebo PBMT/sMF
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Photobiomodulation Therapy, Static Magnetic Fields, Low-Level Laser Therapy, COVID-19, Invasive Mechanical Ventilation, Respiratory Muscles, Intensive Care United

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital Tacchini

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PBMT/sMF

Placebo PBMT/sMF

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival rate
Rate of how many people survived and were discharged and how many died.
Diaphragm muscle function
Diaphragm thickness will be measured by ultrasound.
Platelet count
Platelet count will be measured by blood test.
Leukogram
Leukogram will be measured by blood test.
Erythrogram
Erythrogram will be measured by blood test.
C-reactive protein
C-reactive protein will be measured by blood test.
D-dimer
D-dimer will be measured by blood test.
Immunoglobulin G
Immunoglobulin G will be measured by blood test.
Immunoglobulin M
Immunoglobulin M will be measured by blood test.
Levels of positive end-expiratory pressure (PEEP)
The levels of PEEP will be measured using a mechanical ventilator.
Fraction of inspired oxygen (FiO2)
The levels of FiO2 will be measured using a mechanical ventilator.
Arterial partial pressure of oxygen (PO2)
PO2 will be measured by arterial blood gas analysis.
Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio
PO2/FiO2 ratio will be measured by arterial blood gas analysis.
Levels of tumor necrosis factor-α (TNF-α)
Levels of TNF-α will be measured by blood test.
Levels of vitamin D
Levels of vitamin D will be measured by blood test.

Full Information

First Posted
May 8, 2020
Last Updated
October 28, 2020
Sponsor
University of Nove de Julho
Collaborators
Hospital Tacchini/RS
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1. Study Identification

Unique Protocol Identification Number
NCT04386694
Brief Title
Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With COVID-19
Official Title
Is Photobiomodulation Therapy (PBMT) Combined With Static Magnetic Field (sMF) Able to Decrease the Intensive Care Unit (ICU) Length of Stay for Patients With COVID-19?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
September 17, 2020 (Actual)
Study Completion Date
September 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Hospital Tacchini/RS

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
To achieve the proposed objectives it will be performed a randomized, triple-blind, placebo-controlled trial, with patients admitted to the adult ICU with COVID-19 using invasive mechanical ventilation due to respiratory failure. The patients will be randomly allocated to two treatment groups: 1. Active PBMT/sMF (MR5™ ACTIV PRO LaserShower) or Placebo PBMT/sMF (MR5™ ACTIV PRO LaserShower). The patients will be treated by a blinded therapist, and the patients will be blinded to the treatment received. Since there are no studies in this field, initially it will be randomized 30 patients (15 patients per group) to determine the final sample size for this study. The patients randomly allocated to the two groups will be subjected to treatment once a day, during the ICU stay, until discharge or death. All data will be collected by a blinded assessor. The investigators will analyze: Number of days hospitalized in the ICU until discharge or death. Survival rate: rate of how many people survived and were discharged and how many died. Muscular function of the diaphragm: the first assessment will be performed within 24 hours after the patient's intubation, the second 10 days after the first, and the third at the pre-discharge from the ICU. Blood tests: baseline (admission to the ICU), 10 days after the admission, and endpoint (discharge or death). Mechanical ventilation control parameters: baseline (admission to the ICU), 10 days after the admission, and endpoint (discharge or death). Arterial Blood Gas Analysis: baseline (admission to the ICU), 10 days after the admission, and endpoint (discharge or death). The data regarding the blood tests and arterial blood gas analysis will be collected directly from electronic medical record of each patients, since it is a daily hospital routine to perform these blood tests. The data will be collected by two assessors blinded to the treatment applied. The mechanical ventilation control parameters will be collected directly in the mechanical ventilator. Statistical analysis: All the data will be analyzed by a blinded researcher not involved in data collection. The findings will be tested for their normality using the Kolmogorov-Smirnov test. Parametric data will be expressed as mean and standard deviation and non-parametric data as median and respective upper and lower limits, data can be also expressed as frequency (%). Parametric data will be analysed by two-way repeated measures analysis of variance (time vs experimental group) with post hoc Bonferroni correction. Non-parametric data will be analysed using the Friedman test and, secondarily, the Wilcoxon signed-rank test. The association between categorical variables will be analyzed using the Chi-square test or Fisher's exact test. The significance level will be set at p<0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Respiratory Failure
Keywords
Photobiomodulation Therapy, Static Magnetic Fields, Low-Level Laser Therapy, COVID-19, Invasive Mechanical Ventilation, Respiratory Muscles, Intensive Care United

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PBMT/sMF
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo PBMT/sMF
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active PBMT/sMF
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo PBMT/sMF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time until discharge
Description
Number of days hospitalized in the ICU until discharge or death.
Time Frame
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 Outcome Measure Information:
Title
Survival rate
Description
Rate of how many people survived and were discharged and how many died.
Time Frame
From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days.
Title
Diaphragm muscle function
Description
Diaphragm thickness will be measured by ultrasound.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
Platelet count
Description
Platelet count will be measured by blood test.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
Leukogram
Description
Leukogram will be measured by blood test.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
Erythrogram
Description
Erythrogram will be measured by blood test.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
C-reactive protein
Description
C-reactive protein will be measured by blood test.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
D-dimer
Description
D-dimer will be measured by blood test.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
Immunoglobulin G
Description
Immunoglobulin G will be measured by blood test.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
Immunoglobulin M
Description
Immunoglobulin M will be measured by blood test.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
Levels of positive end-expiratory pressure (PEEP)
Description
The levels of PEEP will be measured using a mechanical ventilator.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
Fraction of inspired oxygen (FiO2)
Description
The levels of FiO2 will be measured using a mechanical ventilator.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
Arterial partial pressure of oxygen (PO2)
Description
PO2 will be measured by arterial blood gas analysis.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio
Description
PO2/FiO2 ratio will be measured by arterial blood gas analysis.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
Levels of tumor necrosis factor-α (TNF-α)
Description
Levels of TNF-α will be measured by blood test.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Title
Levels of vitamin D
Description
Levels of vitamin D will be measured by blood test.
Time Frame
10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients admitted to the adult Intensive Care Unit with Covid-19 infection; Need for orotracheal intubation; Invasive mechanical ventilation due to respiratory failure. Exclusion Criteria: 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.
Facility Information:
Facility Name
Hospital Tacchini
City
Bento Gonçalves
State/Province
RS
ZIP/Postal Code
95700-068
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
34335043
Citation
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.
Results Reference
derived

Learn more about this trial

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

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