Methylene Blue Treatment of COVID-19

NCT04635605 | Completed Phase 2

• 1 other identifier: MB treatment of COVID19
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-CoV2

Outcome Measures

Primary Outcomes (1)

• to compare the viral load kinetics in the enrolled patients with a SARS-CoV-2 positive nasopharyngeal swab demonstrating a reduction of the area under the curve day 0- day 21 of at least 25%

  As primary outcome we will measure the viral load kinetics in the enrolled patients. This means the viral load (expressed as cycled of replication with the PCR method and the number of RNA copies) at baseline and at each scheduled timepoint of the study

  day 0 - day 21

Secondary Outcomes (6)

• To calculate the percentage of patients clearing SARS-CoV-2 by 3, 6, 9, 12, 15 and 21 days after diagnosis

  3, 6, 9, 12, 15 and 21 days after diagnosis

• To calculate the percentage of patients having a reduction of viral load of > 2 log by day 3

  day 3

• To calculate the percentage of patients having a poor outcome as measured by the need of hospitalization for COVID-19

  3, 6, 9, 12, 15, 21, 28 and 84 days after diagnosis

• To calculate the percentage of patients alive

  at 28-days and 84-days

• Safety and tolerability of the administered drug are registered as "adverse events", which are all symptoms related or supposed to be related to the drug that appeared after the drug intake and were NOT present at baseline or before

  3, 6, 9, 12, 15, 21, 28 and 84 days after diagnosis

Study Arms (2)

Methylene Blue

EXPERIMENTAL

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

Drug: Methylene Blue

control group

ACTIVE COMPARATOR

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

Drug: Control Test

Interventions

Methylene Blue 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.

Methylene Blue

Control Test 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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Epatocentro Ticino: lead

Study Sites (1)

Fondazione Epatocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

Location

MeSH Terms

Interventions

Methylene Blue

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: November 19, 2020
• Study Start: November 5, 2020
• Primary Completion: August 13, 2021
• Study Completion: August 13, 2021
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

CH (1)