Methylene Blue Treatment of COVID-19
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04635605 |
Recruitment Status :
Active, not recruiting
First Posted : November 19, 2020
Last Update Posted : April 20, 2022
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Condition or disease | Intervention/treatment | Phase |
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SARS-CoV2 | Drug: Methylene Blue Drug: Control Test | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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 |
Masking: | Triple (Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV2- Affected Patients: a Phase 2, Randomized, Placebo- Controlled, Single Blind Clinical Trial |
Actual Study Start Date : | November 5, 2020 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
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Experimental: 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.
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Drug: 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. |
Active Comparator: control group
The control intervention would be the group receiving 100 mg placebo capsules twice a day for five consecutive days
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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. |
- 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
- 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
- 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
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635605
Switzerland | |
Fondazione Epatocentro Ticino | |
Lugano, Ticino, Switzerland, 6900 |
Responsible Party: | Fondazione Epatocentro Ticino |
ClinicalTrials.gov Identifier: | NCT04635605 |
Other Study ID Numbers: |
MB treatment of COVID19 |
First Posted: | November 19, 2020 Key Record Dates |
Last Update Posted: | April 20, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Methylene Blue Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |