COVID-19 Treatment Using Methylene Blue and Photodynamic Therapy

NCT04933864 | Completed Phase 1 DMC

• 1 other identifier: 2206
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

SARS-CoV-2

Keywords

COVID-19; photodynamic therapy; methylene blue

Outcome Measures

Primary Outcomes (1)

• The percentage of participants with negative quantitative Polymerase Chain Reaction test on SARS-CoV-2 on day 2 after methylene blue administration and photodynamic therapy

  The percentage of participants with negative quantitative Polymerase Chain Reaction test was reported. Quantitative Polymerase Chain Reaction test was performed not earlier than 3-4 hours after the last meal, excluding the use of medicines for topical application (drops, sprays, etc.) before taking the test.

  Day 2

Secondary Outcomes (5)

• Comparison of oxygen saturation dynamics measured by pulse oximeter before and after treatment

  12 and 24 hours after photodynamic therapy

• The percentage of participants with positive dynamics in severity of pneumonia (e.g., from CT-4 to CT-2)

  Day 14

• The percentage of participants having positive dynamics in patient status scale (EQ-5D-3L, SHOCS-COVID score) after treatment

  Day 84

• The percentage of participants alive at day 28

  Day 28

• The percentage of participants alive at day 84

  Day 84

Study Arms (2)

Methylene Blue and Photodynamic Therapy

EXPERIMENTAL

Methylene Blue 1 mg/kg water solution. Participants have orally received Methylene Blue solution of 1 mg/kg concentration one time in addition to the current therapy of the participant (e.g., azithromycin, hydroxychloroquine, aminodihydrophthalazinedione sodium, levofloxacin, etc.), if any. After 3 hours of Methylene Blue administration irradiation of chest using 650 nm laser source with 18 J/cm\^2 energy dose was performed.

Drug: Methylene Blue and Photodynamic Therapy

Control group

NO INTERVENTION

COVID-19 positive participants treated with standard medical supportive therapy (e.g. azithromycin, hydroxychloroquine, aminodihydrophthalazinedione sodium, levofloxacin, etc.).

Interventions

Methylene Blue and Photodynamic Therapy DRUG

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.

Also known as: Methylene Blue (SamaraMedProm, Russia, Registration number: MP-001834, 13.09.2012), 650 nm laser source (UFPh-675-01-BIOSPEC, BIOSPEC, Russia, Registration number: 2009/04648, 26.03.2009)

Methylene Blue and Photodynamic Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consent
• age: 18-90 years
• positive quantitative Polymerase Chain Reaction test on SARS-CoV-2 infection
• negative pregnancy test in women
• any severity of pneumonia (computer tomography scans)
• documented refusal to participate in the study
• treatment with a serotonergic drug
• connection to artificial lung ventilation with or without sedation
• history of G-6-Phosphatase deficiency
• pregnancy and breastfeeding
• medical records of cirrhosis
• active chronic hepatitis

You may not qualify if:

• myocardial infarction, developed after the patient was included in the study, but before the intervention
• bleeding, developed after the patient was included in the study, but before the intervention
• connection to artificial lung ventilation developed after the patient was included in the study, but before the intervention

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead
• Prokhorov General Physics Institute of the Russian Academy of Sciences (GPI RAS): collaborator

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

Location

Related Publications (1)

• Strakhovskaya, M. G., Meerovich, G. A., Kuskov, A. N., Gonchukov, S. A., & Loschenov, V. B. (2020, September 1). Photoinactivation of coronaviruses: Going along the optical spectrum. Laser Physics Letters. IOP Publishing Ltd. https://doi.org/10.1088/1612-202X/abab14

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Methylene Blue; Photochemotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Igor V. Reshetov, Prof.

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  STUDY DIRECTOR

• Artem A. Shiryaev, Ph.D.

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

• Victor B. Loschenov, Prof.

  Prokhorov General Physics Institute of the Russian Academy of Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 22, 2021
• Study Start: April 24, 2020
• Primary Completion: May 20, 2020
• Study Completion: July 30, 2020
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)