Methylene Blue Treatment of COVID-19

Fondazione Epatocentro Ticino

Status and phase: Completed; Phase 2

Conditions: SARS-CoV2

Treatments: Drug: Control Test; Drug: Methylene Blue

Study type: Interventional

Funder types: Other

Identifiers

NCT04635605

MB treatment of COVID19

Details and patient eligibility

About

Despite enormous progress in understanding COVID-19, there is little evidence that a solution, therapeutic or preventive, is close to being achieved. Repurposing of well known, widely available drugs represent an attractive approach to speed up availability of active treatments. Such substances as i.e. hydroxychloroquine and others, are already under investigation and in widespread off label use. For many reasons Methylene blue (MB), the oldest synthetic substance in medicine (1876 synthesized by BASF) is such a promising candidate for an active treatment against SARS-CoV-2 infected people and for COVID-19 patients.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria are:

• signed informed consent
• age ≥ 18 years
• microbiologically confirmed SARS-CoV-2 infection
• negative pregnancy test in women of child-bearing age

Exclusion criteria are:

• documented refusal to participate in the study
• known G-6-Phophatase deficiency
• treatment with a serotoninergic drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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29 participants in 2 patient groups

Methylene Blue

Experimental group

Description:

Methylene Blue 100 mg capsules. Patients will receive Methylene blue (MB) capsules of 100mg every 12 hours for a total of 5 days.

Treatment:

Drug: Methylene Blue

control group

Active Comparator group

Description:

The control intervention would be the group receiving 100 mg placebo capsules twice a day for five consecutive days

Treatment:

Drug: Control Test