Methylene Blue Treatment of COVID-19

SARS-CoV2 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04635605
• Other study ID #: MB treatment of COVID19
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 5, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: Fondazione Epatocentro Ticino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Fondazione Epatocentro Ticino	Lugano	Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Epatocentro Ticino

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To calculate the percentage of patients clearing SARS-CoV-2 by 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	3, 6, 9, 12, 15 and 21 days after diagnosis
Secondary	To calculate the percentage of patients having a reduction of viral load of > 2 log by 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	day 3
Secondary	To calculate the percentage of patients having a poor outcome as measured by the need of hospitalization for COVID-19	We calculate the number of patients (expressed as percentage) that need hospitalization due to COVID-19, within the timeframe of the study	3, 6, 9, 12, 15, 21, 28 and 84 days after diagnosis
Secondary	To calculate the percentage of patients alive	We calculate the number of patients (expressed as percentage) still alive at day 28 and 84 of samples collection	at 28-days and 84-days
Secondary	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	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	3, 6, 9, 12, 15, 21, 28 and 84 days after diagnosis
Secondary	To measure the compliance by calculating the number of capsules taken by the patient and the overall number of patients who complete the treatment	We calculate the number of pills (expressed as absolute number) taken by each enrolled patient during the study	3, 6, 9, 12, 15 and 21 days after diagnosis