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Methylene Blue Treatment of COVID-19

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ClinicalTrials.gov Identifier: NCT04635605
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Fondazione Epatocentro Ticino

Study Description
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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.

Condition or disease Intervention/treatment Phase
SARS-CoV2 Drug: Methylene Blue Drug: Control Test Phase 2

Study Design
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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, 2021
Estimated Study Completion Date : December 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
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.
 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
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Switzerland
Fondazione Epatocentro Ticino Recruiting
Lugano, Ticino, Switzerland, 6900
Contact: Andreas Cerny, Prof    +41919608503    andreas.cerny@hin.ch   
Contact: Maurizia Bissig    +41919608503    maurizia.bissig@hin.ch   
Sponsors and Collaborators
Fondazione Epatocentro Ticino
More Information
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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: February 2, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action