CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Active PBMT/sMFWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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drug1834 Placebo PBMT/sMF Wiki 1.00

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There is one clinical trial.

Clinical Trials


1 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?

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.

NCT04386694 COVID-19 Respiratory Failure Device: Active PBMT/sMF Device: Placebo PBMT/sMF
MeSH:Respiratory Insufficiency

Primary Outcomes

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

Measure: Time until discharge

Time: 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

Description: Rate of how many people survived and were discharged and how many died.

Measure: Survival rate

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

Description: Diaphragm thickness will be measured by ultrasound.

Measure: Diaphragm muscle function

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

Description: Platelet count will be measured by blood test.

Measure: Platelet count

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

Description: Leukogram will be measured by blood test.

Measure: Leukogram

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

Description: Erythrogram will be measured by blood test.

Measure: Erythrogram

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

Description: C-reactive protein will be measured by blood test.

Measure: C-reactive protein

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

Description: D-dimer will be measured by blood test.

Measure: D-dimer

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

Description: Immunoglobulin G will be measured by blood test.

Measure: Immunoglobulin G

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

Description: Immunoglobulin M will be measured by blood test.

Measure: Immunoglobulin M

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

Description: The levels of PEEP will be measured using a mechanical ventilator.

Measure: Levels of positive end-expiratory pressure (PEEP)

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

Description: The levels of FiO2 will be measured using a mechanical ventilator.

Measure: Fraction of inspired oxygen (FiO2)

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

Description: PO2 will be measured by arterial blood gas analysis.

Measure: Arterial partial pressure of oxygen (PO2)

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

Description: PO2/FiO2 ratio will be measured by arterial blood gas analysis.

Measure: Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio

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

Description: Levels of TNF-α will be measured by blood test.

Measure: Levels of tumor necrosis factor‐α (TNF-α)

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

Description: Levels of vitamin D will be measured by blood test.

Measure: Levels of vitamin D

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


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