Clinical trial NCT04635605: Methylene Blue Treatment of COVID-19
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: SARS-CoV2
Lead sponsor: Fondazione Epatocentro Ticino
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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%
timeFrame: day 0 - day 21
Secondary outcomes:
measure: To calculate the percentage of patients clearing SARS-CoV-2 by 3, 6, 9, 12, 15 and 21 days after diagnosis
timeFrame: 3, 6, 9, 12, 15 and 21 days after diagnosis
measure: To calculate the percentage of patients having a reduction of viral load of > 2 log by day 3
timeFrame: day 3
measure: To calculate the percentage of patients having a poor outcome as measured by the need of hospitalization for COVID-19
timeFrame: 3, 6, 9, 12, 15, 21, 28 and 84 days after diagnosis
measure: To calculate the percentage of patients alive
timeFrame: at 28-days and 84-days
measure: 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
timeFrame: 3, 6, 9, 12, 15, 21, 28 and 84 days after diagnosis
measure: To measure the compliance by calculating the number of capsules taken by the patient and the overall number of patients who complete the treatment
timeFrame: 3, 6, 9, 12, 15 and 21 days after diagnosis
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Fondazione Epatocentro Ticino
state: Ticino
Study officials:
References: