COVID-19 Treatment Using Methylene Blue and Photodynamic Therapy

What Was Tested

The trial (phase 1) is built around Methylene blue (non-peptide stack partner).

According to the epidemiological situation worldwide and the number of vaccinations made, there is little success in the fight against COVID-19.

Since methylene blue can work as a photosensitizer, photodynamic therapy as an antiviral treatment has great potential in the treatment of COVID-19.

It had two arms (groups): Methylene Blue and Photodynamic Therapy (experimental) and Control group (no intervention).

The registry classes the interventions as drug.

More on the Plan

This is a randomized, parallel, single masking clinical study 60 participants aged 18-90 with one positive COVID-19 quantitative Polymerase Chain Reaction test and any severity of pneumonia (checked by computer tomography scans) were recruited.

The experimental and control samples included 30 participants.

Randomization was performed using the Random Number Table generated in STATISTICA Advanced 13.3.

The physiological parameters including oxygen saturation, severity of pneumonia using computer tomography scans, heart rate, symptoms, and physical examination were collected.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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).

The full record lists 12 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

In this single-blind Methylene blue (non-peptide stack partner) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2020-04-24 with completion listed for 2020-05-20.

It ran at 1 site in Russia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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 (time frame: Day 2).

It also tracked 5 secondary outcomes, for example Comparison of oxygen saturation dynamics measured by pulse oximeter before and after treatment, The percentage of participants with positive dynamics in severity of pneumonia (e.g., from CT-4 to CT-2), The percentage of participants having positive dynamics in patient status scale (EQ-5D-3L, SHOCS-COVID score) after treatment, The percentage of participants alive at day 28 and The percentage of participants alive at day 84.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Methylene blue (non-peptide stack partner) in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.