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Photodynamic Therapy for the Treatment of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04416113
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Abeer Attia Tawfik, Cairo University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Photodynamic Therapy& Low Level Laser in Management of COVID 19 Procedure: photobiomodulation and photodynamic therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 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.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Photobiomodulation and Photodynamic Therapy for the Treatment of COVID-19 A Randomized Controlled Clinical Trials
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

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 Name: 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 Name: conventional

Active Comparator: positive control
This group will include patients who are subjected to conventional treatment
Procedure: photobiomodulation and photodynamic therapy
antiviral treatment
Other Name: conventional




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Publications:
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Responsible Party: Abeer Attia Tawfik, professor of dermatology and laser at national institute of laser enhanced sciences, Cairo University
ClinicalTrials.gov Identifier: NCT04416113    
Other Study ID Numbers: Cu-NILES/16/20
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: if the results are positive we will invite other researchers to share

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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
Keywords provided by Abeer Attia Tawfik, Cairo University:
photodynamic therapy
low level laser therapy
COVID 19 virus