SARS-CoV2
Conditions
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.
Interventions
DRUGMethylene 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.
DRUGControl 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.
Sponsors
Fondazione Epatocentro Ticino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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 |
Countries
Switzerland
Outcome results
None listed