Methylene Blue Treatment of COVID-19

NCT ID: NCT04635605

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2021-08-13

Brief Summary

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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.

Detailed Description

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Conditions

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SARS-CoV2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a phase 2 proof of concept, randomized, placebo controlled, single blind clinical trial on the efficacy of Methylene Blue against SARS-CoV-2 infection in patients with recently diagnosed SARS-CoV-2 infection
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Methylene Blue

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

Group Type EXPERIMENTAL

Methylene Blue

Intervention Type DRUG

Treatment Group. Methylene Blue 100 mg capsules, twice a day for 5 consecutive days, will be added to the current therapy of the patient, if any.

control group

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

Group Type ACTIVE_COMPARATOR

Control Test

Intervention Type DRUG

Arm B: Control Group. Placebo capsules 100 mg twice a day for 5 consecutive days, will be added to the current therapy of the patient, if any.

Interventions

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Methylene Blue

Treatment Group. Methylene Blue 100 mg capsules, twice a day for 5 consecutive days, will be added to the current therapy of the patient, if any.

Intervention Type DRUG

Control Test

Arm B: Control Group. Placebo capsules 100 mg twice a day for 5 consecutive days, will be added to the current therapy of the patient, if any.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* documented refusal to participate in the study
* known G-6-Phophatase deficiency
* treatment with a serotoninergic drug
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Epatocentro Ticino

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Epatocentro Ticino

Lugano, Canton Ticino, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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MB treatment of COVID19

Identifier Type: -

Identifier Source: org_study_id

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