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临床试验/NCT04416113
NCT04416113Unknown不适用

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

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Participants Achieving Either a Major Clinical Response or Partial Clinical Response (PCR) Defined by WHO

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients in critical cases who admitted to the ICU, bacterial pneumonia, and respiratory distress grade III, IV, and patients on a mechanical ventilator.

结局指标

主要结局

Participants Achieving Either a Major Clinical Response or Partial Clinical Response (PCR) Defined by WHO

时间窗: 2 weeks

Molecular-based assays: * N COV 2019 * Antigen assays: * SARS (COV) antigen, Serology assays: * N COV 2019 antibodies medical respiratory clearance questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abeer Attia Tawfik

professor of dermatology and laser at national institute of laser enhanced sciences

Cairo University

研究点 (2)

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