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COVID-19 Treatment Using Methylene Blue and Photodynamic Therapy

NCT04933864 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-06-22

No results posted yet for this study

Summary

According to the epidemiological situation worldwide and the number of vaccinations made, there is little success in the fight against COVID-19. For many reasons, methylene blue is a promising drug for an active treatment against SARS-CoV-2 infected patients. Since methylene blue can work as a photosensitizer, photodynamic therapy as an antiviral treatment has great potential in the treatment of COVID-19. This clinical study investigated the effectiveness of SARS-CoV-2 infected people treatment using methylene blue and the following photodynamic therapy on the base of the L.L. Levshin Institute of Cluster Oncology (Department of Infectious Diseases №13) of I.M. Sechenov First Moscow State Medical University.

Conditions

Interventions

DRUG

Methylene Blue and Photodynamic Therapy

Treatment group. Methylene blue (SamaraMedProm, Russia, Registration number: MP-001834, 13.09.2012) 1 mg/kg concentration orally one time were added to the current therapy of the participant (e.g., azithromycin, hydroxychloroquine, aminodihydrophthalazinedione sodium, levofloxacin, etc.), if any, and irradiation of the participant's chest was performed by 650 nm laser source (UFPh-675-01-BIOSPEC, BIOSPEC, Russia, Registration number: 2009/04648, 26.03.2009) with 18 J/cm\^2 energy dose. For critically ill participants: Inhalation by 0.2 mg methylene blue (SamaraMedProm, Russia, Registration number: MP-001834, 13.09.2012) 10 ml water solution and irradiation of pharynx and nasal cavity by 650 nm laser source (UFPh-675-01-BIOSPEC, BIOSPEC, Russia, Registration number: 2009/04648, 26.03.2009) with 36 J/cm\^2 energy dose were performed.

Sponsors & Collaborators

  • Prokhorov General Physics Institute of the Russian Academy of Sciences (GPI RAS)

    collaborator UNKNOWN

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Igor V. Reshetov, Prof. · I.M. Sechenov First Moscow State Medical University (Sechenov University)

  • Artem A. Shiryaev, Ph.D. · I.M. Sechenov First Moscow State Medical University (Sechenov University)

  • Victor B. Loschenov, Prof. · Prokhorov General Physics Institute of the Russian Academy of Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-24
Primary Completion
2020-05-20
Completion
2020-07-30

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04933864 on ClinicalTrials.gov