Until now there is no vaccine or reliable treatment for the COVID-19 pandemic. Thefundamental mechanisms of non-invasive low-level laser in photobiomodulation (PBM) andphotodynamic therapy is to stimulate the mitochondrial respiratory chain where atransient release of non-cytotoxic levels of reactive oxygen species (ROS) will lead topositive modulation of the immune response. As previous studies mentioned that the mostimportant strategy for COVID-19 management is oxygenation and faster rehabilitation ofthe damaged tissue, antiviral effects, and, finally, reduction or controlling the cytokinestorm by reducing inflammatory agents. PBM may be used as adjuvant therapy or even analternative therapy in all these mechanisms without side effects and drug interactions.Objectives The objective of this clinical trial is to use the photobiomodulation therapy(PBMT), and photodynamic therapy as adjuvant therapy or even an alternative therapy forCovide-19.Patients and methods A randomized controlled study will be conducted on 60 patients ofpositive COVID 19. The patients will be divided into 3 equal groups. Group, I willreceive a low-level laser (diode laser 980nm) from laser watch for 30 minutes, 20 J for 3to 5 days, and laser acupuncture. Group 2 will be treated with photodynamic therapy byinjecting the methylene blue as a photosensitizer and irradiated with laser watch (diodelaser 670 nm). Group 3 will serve as a control. Evaluation methods will includelaboratory investigations and CT chest.
Treatment protocol:
This clinical study was conducted following the approval of the research ethics committee
for experimental and clinical studies at the National Institute of Laser Enhanced
Sciences, Cairo University, Egypt (approval number CU-NILES/16/20 May 2020) with the
principles outlined in the Declaration of Helsinki for human subject experimentation
being followed. Informed consent will be obtained from the patients, and the privacy
rights will be continuously observed.
This study will be conducted on 60 patients with COVID 19 of all ages and both sex.
Patients will be divided into 3 groups:
Group 1: photobiomodulation This group included the use of laser watch and laser
acupuncture
Laser watch Patients will be subjected to low level laser (diode laser 980nm) for 30
minutes, the recommended dose based on previous study is 20 J for 3 to 7 days.
The laser device:
Laser watched applied at the wrist on the radial artery.
Laser acupuncture Patients will receive laser acupuncture using pulsed infra- red laser,
wavelength 880 / 905/980 nm, spot size diameter of 5 mm frequency 2500 Hz, average power
15 W, energy of 225 mJ applied for 2 min per point and pulse width of 100 ns and area =
0.2 cm2. Patients will receive one session daily for 7 days.
Laser acupuncture was applied at the following points (World Health Organization 2008).
The points where the laser acupuncture will be applied are demonstrated in the following
figures:
- For cough and chest tightness, wheezes and congestion: LU1, 2, 5, 7, 9, 14 (fig.1)
For improving immunity and blood circulation, also for dyspnea and GIT manifestation
also, breaks up blood stagnation in the chest: ST36
- Affects the throat, chest, lungs: CV12, CV4 Sore throat, coughing, & asthma: KI3 Fig
- Laser acupuncture device could be applied simultaneously on all points same time by
special multi-channel device (fig3)
Group 2 (photodynamic therapy) Methylene blue injection USP 1% will be used as a
photosensitizer in PDT.
- 0.1 to 0.2 mL of 1% solution per kilogram of body weight Methylene Blue (methylene
blue injection) will be injected intravenously very slowly over a period of several
minutes to prevent local high concentration of the compound from producing
methemoglobin (low concentrations will convert methemoglobin to hemoglobin and will
be activated by light).
- After one hour apply Light dose: 100 - 200 J/cm2 50-100 mW/cm2. (50 mW/cm2 increased
the phototoxic response as well as fractionated light application).
- Session will be done twice per week
The laser device:
Laser watched applied at the wrist on the radial artery. Group 3: positive control This
group will include patients who are subjected to conventional treatment Evaluation and
assessment All patients will be subjected to thorough examination with complete personal
and clinical history and will do the following before and after treatment: PCR, CBC, CRP,
ESR, D dimers, liver enzymes, and Ferritin, CT chest
Endpoint Treatment will be stopped if no improvement occurred after one week
Statistical analysis
All statistical calculations were done using computer programs SPSS (Statistical Package
for the Social Science; SPSS Inc., Chicago, IL) v.16 for Microsoft Windows. Continuous
variables were tested for normality by the Shapiro-Wilk normality test. Values are
presented as mean ± standard deviation, or in the case of non-normally distributed data
as median and inter-quartile range. For comparison between paired parameters (before and
after treatment), paired t-test or the Wilcoxon matched-pairs signed-rank test were used
according to data normality. For comparison between independent groups, the chi-squared
test was used to compare percentages between different groups of patients. Normally
distributed data were analyzed using independent samples t-test. Non-normally distributed
data were analyzed using the Mann-Whitney U-test. p values <.05 were considered
statistically significant.
Procedure: photobiomodulation and photodynamic therapy
antiviral treatment
Other Name: conventional
Inclusion Criteria:
- Hospitalized patients with Positive COVID 19 test suffering from Fever, cough,
shortness of breath, chills, muscle pain, the new loss of taste or smell, vomiting
or diarrhea, and/or sore throat
Exclusion Criteria:
- Patients in critical cases who admitted to the ICU, bacterial pneumonia, and
respiratory distress grade III, IV, and patients on a mechanical ventilator.
Abeer Attia Tawfik
Giza, Egypt