NCT04386694

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

Completed NA Last updated 29 October 2020

What this trial tests

NA trial testing Active PBMT/sMF in COVID-19 in 30 participants. Completed in 17 September 2020.

Timeline

18 May 2020

Primary endpoint
17 September 2020

17 September 2020

Quick facts

Lead sponsor	University of Nove de Julho
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	18 May 2020
Primary completion	17 September 2020
Estimated completion	17 September 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Active PBMT/sMF
• Placebo PBMT/sMF

Conditions studied

• COVID-19 — all drugs for COVID-19 →
• Respiratory Failure — all drugs for Respiratory Failure →

Sponsor

University of Nove de Julho

Who can join

15 and older, any sex, with COVID-19 or Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Understanding COVID-19 Pandemic: Molecular Mechanisms and Potential Therapeutic Strategies. An Evidence-Based Review.
   Hanna R, Dalvi S, Sălăgean T, Pop ID, et al · · 2021 · cited 28× · PMID 33447071 · DOI 10.2147/jir.s282213
2. Effects of Photobiomodulation Therapy Combined with Static Magnetic Field in Severe COVID-19 Patients Requiring Intubation: A Pragmatic Randomized Placebo-Controlled Trial.
   De Marchi T, Frâncio F, Ferlito JV, Weigert R, et al · · 2021 · cited 21× · PMID 34335043 · DOI 10.2147/jir.s318758
3. Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.
   Mathioudakis AG, Fally M, Hashad R, Kouta A, et al · · 2020 · cited 14× · PMID 33333777 · DOI 10.3390/life10120350
4. A Potential Role for Photobiomodulation Therapy in Disease Treatment and Prevention in the Era of COVID-19.
   Liebert A, Bicknell B, Markman W, Kiat H. · · 2020 · cited 13× · PMID 33269093 · DOI 10.14336/ad.2020.0901
5. Effects of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) in patients with severe COVID-19 requiring intubation: a pragmatic randomized placebo-controlled trial
   De Marchi T, Frâncio F, Ferlito JV, Weigert RM, et al · · 2020 · DOI 10.1101/2020.12.02.20237974