Methylene Blue Treatment of COVID-19

Sponsor

Fondazione Epatocentro Ticino (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04635605

Collaborator

(none)

Enrollment

Location

Arms

37.8

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 infectionThis 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 :

Nov 5, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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

Primary Outcome Measures

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% [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

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]
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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Epatocentro Ticino	Lugano	Ticino	Switzerland	6900

Sponsors and Collaborators

Fondazione Epatocentro Ticino

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Epatocentro Ticino

ClinicalTrials.gov Identifier:

NCT04635605

Other Study ID Numbers:

MB treatment of COVID19

First Posted:

Nov 19, 2020

Last Update Posted:

Apr 20, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Methylene Blue

Study Results

No Results Posted as of Apr 20, 2022