COVID-19 Methylene Blue Antiviral Treatment

What Was Tested

In this phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had two arms (groups): Methylene blue Arm (experimental) and Saline solution Arm (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Regarding the recovery of patients with COVID-19, this is defined as a negative PCR test result for the SARS-CoV-2 coronavirus in swabs from the nasopharynx and oropharynx on the 14th and 28th day after initiation of the experimental treatment.

Due to the pilot nature of this study, another goal is to calculate the effect based on the number of subjects per group for a future study.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and women aged 18 and over at the time of signing the informed consent. The patient is willing and able to give written informed consent to participate in the study and follow the procedures specified in the protocol. Diagnosed with COVID-19, confirmed by a PCR test positive for the SARS-CoV-2 coronavirus in smears from the nasopharynx and oropharynx. Indications for hospitalization for COVID-19 treatment: a moderate condition that does not require oxygen support or low oxygen flow required through a nasal cannula or oxygen mask. A urine test performed during screening, negative for pregnancy in women capable of childbearing.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: topical or systemic use of methylene blue for any reasons at the time of evaluation or during the interval of 30 days before hospitalization; patients with a high probability of not surviving within the first 24 h of hospitalization, regardless of the treatment, as defined by the investigator.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2021-08-06 with completion listed for 2021-12-12.

It ran at 1 site in Russia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Recovery (time frame: Day 14 after randomization). Recovery (time frame: Day 28 after randomization).

It also tracked 5 secondary outcomes, for example Clinical responce, Overall therapeutic response, Resolution rate, Clinical responce FUV and Overall therapeutic response FUV.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 24 people.

Its size is small, so on its own it can only give an early look.

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.