Clinical Application of Methylene Blue for Treatment of Covid-19 Patients

What Was Tested

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

The severe acute respiratory syndrome caused by COVID-19 is now a global catastrophic event.

Currently there is no approved drug or vaccine for the disease.

Methylene blue (MB, oxidized form, blue color) has been used in many different areas of clinical medicine, ranging from malaria to orthopedics.

It had two arms (groups): Control group (no intervention) and Intervention group (experimental).

Covid-19 patients treated with mixture of MCN (Methylene blue, vitamin C, N-acetyl cysteine).

The registry classes the interventions as drug.

Who Took Part

20 planned participants were the target.

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

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

Examples of who could join: Confirmed case of Covid-19 (by RT-PCR, HRCT). Admission to Intensive Care Unit. Need for intubation and mechanical ventilation (PaO2/FiO2 \< 100-200). Written informed consent.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: pregnancy and breastfeeding; history of g6pdh deficiency; preadmission anticoagulation.

How the Study Was Run

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

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 2020-04-19 with completion listed for 2020-09-20.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of patients remaining free of need for mechanical ventilation in both groups (time frame: Day 7).

It also tracked 7 secondary outcomes, for example Mortality rate in both groups, Duration of hospital stay in both group, Duration of Intensive Care Unit stay in both groups, Days free of dialysis in both groups, C-reactive proteins and WBC Count.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Methylene blue (non-peptide stack partner) in 20 people.

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

Its status is unknown; 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.