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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
29
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.
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.
Fondazione Epatocentro Ticino
Lugano, Canton Ticino, Switzerland
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
Time frame: day 0 - day 21
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
Time frame: 3, 6, 9, 12, 15 and 21 days after diagnosis
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
Time frame: day 3
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
Time frame: 3, 6, 9, 12, 15, 21, 28 and 84 days after diagnosis
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
Time frame: at 28-days and 84-days
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
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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
Time frame: 3, 6, 9, 12, 15, 21, 28 and 84 days after diagnosis
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
Time frame: 3, 6, 9, 12, 15 and 21 days after diagnosis