COVID-19NCT04386694
Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With COVID-19
A study testing Active PBMT/sMF in people with COVID-19 and Respiratory Failure, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- COVID-19, Respiratory Failure
- What is being tested?
- Active PBMT/sMF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 18 May 2020to 17 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted to the adult Intensive Care Unit with Covid-19 infection;
- Need for orotracheal intubation;
- Invasive mechanical ventilation due to respiratory failure.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
Read more
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.
Read the 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.
- Conditions
- COVID-19, Respiratory Failure
- Being tested
- Active PBMT/sMF, Placebo PBMT/sMF
- Keywords
- Photobiomodulation Therapy, Static Magnetic Fields, Low-Level Laser Therapy, COVID-19, Invasive Mechanical Ventilation, Respiratory Muscles, Intensive Care United
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PBMT/sMFDevice
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.
Placebo PBMT/sMFDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo PBMT/sMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until discharge
Number of days hospitalized in the ICU until discharge or death.
Measured: 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
Rate of how many people survived and were discharged and how many died.
Measured: 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
Diaphragm thickness will be measured by ultrasound.
Measured: 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
Platelet count will be measured by blood test.
Measured: 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
Leukogram will be measured by blood test.
Measured: 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
Erythrogram will be measured by blood test.
Measured: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
C-reactive protein
C-reactive protein will be measured by blood test.
Measured: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
D-dimer
D-dimer will be measured by blood test.
Measured: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Immunoglobulin G
Immunoglobulin G will be measured by blood test.
Measured: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Immunoglobulin M
Immunoglobulin M will be measured by blood test.
Measured: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Levels of positive end-expiratory pressure (PEEP)
The levels of PEEP will be measured using a mechanical ventilator.
Measured: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Fraction of inspired oxygen (FiO2)
The levels of FiO2 will be measured using a mechanical ventilator.
Measured: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Arterial partial pressure of oxygen (PO2)
PO2 will be measured by arterial blood gas analysis.
Measured: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio
PO2/FiO2 ratio will be measured by arterial blood gas analysis.
Measured: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Levels of tumor necrosis factor-α (TNF-α)
Levels of TNF-α will be measured by blood test.
Measured: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Levels of vitamin D
Levels of vitamin D will be measured by blood test.
Measured: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start18 May 2020
- Primary completion17 Sep 2020
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Tacchini/RS
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386694
- Sponsor's protocol ID
- 3.985.226
- Status last verified
- Oct 2020
- First submitted
- 8 May 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 34335043
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT04386694
- Acronym / sponsor ID
- 3.985.226
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Hospital Tacchini/RS
- Study start
- 18 May 2020 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBMT/sMF | Experimental | Device: Active PBMT/sMFActive 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 | Placebo comparator | Device: Placebo PBMT/sMFPlacebo 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to the adult Intensive Care Unit with Covid-19 infection;
- Need for orotracheal intubation;
- Invasive mechanical ventilation due to respiratory failure.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active PBMT/sMFThe 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. | Device | PBMT/sMF |
| Placebo PBMT/sMFThe 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. | Device | Placebo PBMT/sMF |
Primary outcome
Time until discharge
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.
Number of days hospitalized in the ICU until discharge or death.
15 secondary outcomes
Survival rate
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.
Diaphragm muscle function
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.
Platelet count
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.
Leukogram
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.
Erythrogram
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.
C-reactive protein
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.
D-dimer
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.
Immunoglobulin G
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.
Immunoglobulin M
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.
Levels of positive end-expiratory pressure (PEEP)
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.
Fraction of inspired oxygen (FiO2)
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.
Arterial partial pressure of oxygen (PO2)
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.
Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio
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.
Levels of tumor necrosis factor-α (TNF-α)
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.
Levels of vitamin D
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Derived from this study: PubMed 34335043De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active PBMT/sMF in people with COVID-19 and Respiratory Failure, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until discharge (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04386694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.