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OpenTrials
Completed

NCT Number: NCT04635605

Methylene Blue Treatment of COVID-19

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.

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Key information

Conditions

Sars-CoV2

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fondazione Epatocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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%

    Time frame: day 0 - day 21

    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

Secondary outcomes

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

    Time frame: 3, 6, 9, 12, 15 and 21 days after diagnosis

    We report the number of patients (expressed as percentage) with negative oro-pharyngeal swab at the scheduled time-points

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

    Time frame: day 3

    We calculate the number of patients (expressed as percentage) that have a decreased viral load (expressed as RNA copies) greater than 2 log by day three

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

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

    We calculate the number of patients (expressed as percentage) that need hospitalization due to COVID-19, within the timeframe of the study

  4. To calculate the percentage of patients alive

    Time frame: at 28-days and 84-days

    We calculate the number of patients (expressed as percentage) still alive at day 28 and 84 of samples collection

  5. 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

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

    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 Adverse events are expressed as present (1) or absent (0), in the dedicated data sheet which will be collected at each scheduled visit

  6. To measure the compliance by calculating the number of capsules taken by the patient and the overall number of patients who complete the treatment

    Time frame: 3, 6, 9, 12, 15 and 21 days after diagnosis

    We calculate the number of pills (expressed as absolute number) taken by each enrolled patient during the study

Sponsors and collaborators

Lead sponsor

Fondazione Epatocentro Ticino

Other

Registry information

Official study title

Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV2- Affected Patients: a Phase 2, Randomized, Placebo- Controlled, Single Blind Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2020
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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