Photodynamic Therapy for the Treatment of COVID-19

August 5, 2021 updated by: Abeer Attia Tawfik, Cairo University

Photobiomodulation and Photodynamic Therapy for the Treatment of COVID-19 A Randomized Controlled Clinical Trials

Until now there is no vaccine or reliable treatment for the COVID-19 pandemic. The fundamental mechanisms of non-invasive low-level laser in photobiomodulation (PBM) and photodynamic therapy is to stimulate the mitochondrial respiratory chain where a transient release of non-cytotoxic levels of reactive oxygen species (ROS) will lead to positive modulation of the immune response. As previous studies mentioned that the most important strategy for COVID-19 management is oxygenation and faster rehabilitation of the damaged tissue, antiviral effects, and, finally, reduction or controlling the cytokine storm by reducing inflammatory agents. PBM may be used as adjuvant therapy or even an alternative 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 for Covide-19.

Patients and methods A randomized controlled study will be conducted on 60 patients of positive COVID 19. The patients will be divided into 3 equal groups. Group, I will receive a low-level laser (diode laser 980nm) from laser watch for 30 minutes, 20 J for 3 to 5 days, and laser acupuncture. Group 2 will be treated with photodynamic therapy by injecting the methylene blue as a photosensitizer and irradiated with laser watch (diode laser 670 nm). Group 3 will serve as a control. Evaluation methods will include laboratory investigations and CT chest.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11236
        • Abeer Attia Tawfik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: photobiomodulation group

Laser watch Patients will be subjected to low-level laser (diode laser 980nm) for 30 minutes, the recommended dose based on the 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
Procedure: photobiomodulation and photodynamic therapy
antiviral treatment
Other Names:
  • conventional
Active Comparator: photodynamic group

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
  • After one hour apply Light dose: 100 - 200 J/cm2 50-100 mW/cm2. (50 mW/cm2 increased the phototoxic response as well as the fractionated light application).
  • The session will be done twice per week

Laser watched applied at the wrist on the radial artery.
Procedure: photobiomodulation and photodynamic therapy
antiviral treatment
Other Names:
  • conventional
Active Comparator: positive control
This group will include patients who are subjected to conventional treatment
Procedure: photobiomodulation and photodynamic therapy
antiviral treatment
Other Names:
  • conventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants Achieving Either a Major Clinical Response or Partial Clinical Response (PCR) Defined by WHO
Time Frame: 2 weeks

Molecular-based assays:

  • N COV 2019
  • Antigen assays:
  • SARS (COV) antigen, Serology assays:
  • N COV 2019 antibodies medical respiratory clearance questionnaire
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

May 24, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cu-NILES/16/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

if the results are positive we will invite other researchers to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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