Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV-2-Affected Patients: A Proof-of-Concept Phase 2, Randomized, Placebo-Controlled, Single-Blind Clinical Trial
The SARS-CoV-2 pandemic has revolutionized the scientific and medical world in recent years. Methylene blue (MB) is a well-known molecule. The aim of our study was to assess the efficacy of MB against early-phase SARS-CoV-2 infections. All patients with a positive swab for SARS-CoV-2 were eligible f...
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MDPI AG
2024-10-01
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| author | Beatrice Barda Bruno Di Mari Emiliano Soldini Claudia Di Bartolomeo Maurizia Bissig Adriana Baserga Antonella Robatto Lorenzo Magenta Rossella Forlenza Andreas Cerny |
| author_facet | Beatrice Barda Bruno Di Mari Emiliano Soldini Claudia Di Bartolomeo Maurizia Bissig Adriana Baserga Antonella Robatto Lorenzo Magenta Rossella Forlenza Andreas Cerny |
| author_sort | Beatrice Barda |
| collection | DOAJ |
| description | The SARS-CoV-2 pandemic has revolutionized the scientific and medical world in recent years. Methylene blue (MB) is a well-known molecule. The aim of our study was to assess the efficacy of MB against early-phase SARS-CoV-2 infections. All patients with a positive swab for SARS-CoV-2 were eligible for the trial. The intervention was a starting dose of 200 mg MB or placebo in the morning and 100 mg in the evening on the first day and afterwards the standard daily dose of 200 mg. Patients were followed up for safety and efficacy until day 84. We analyzed 21 patients for the safety profile and 19 for the efficacy objective: of these, there were 11 in the MB group and 8 in the placebo one. In both groups, patients had undetectable RNA from day 3 and 10 out of 11 subjects in the MB group were virus free by day 12 vs. 6 out of 8 in the placebo one. None of the patients experienced serious adverse events. MB has proved to be a safe and well-tolerated drug. We did not find superiority of efficacy or viral clearance of MB compared to the placebo. Given the good in vitro efficacy, larger studies are needed to assess MB efficacy against COVID-19 in vivo. |
| format | Article |
| id | doaj-art-5305d488bfac44e5b07f9a1ee167b28e |
| institution | DOAJ |
| issn | 0036-8709 2218-0532 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Scientia Pharmaceutica |
| spelling | doaj-art-5305d488bfac44e5b07f9a1ee167b28e2025-08-20T02:57:17ZengMDPI AGScientia Pharmaceutica0036-87092218-05322024-10-019245610.3390/scipharm92040056Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV-2-Affected Patients: A Proof-of-Concept Phase 2, Randomized, Placebo-Controlled, Single-Blind Clinical TrialBeatrice Barda0Bruno Di Mari1Emiliano Soldini2Claudia Di Bartolomeo3Maurizia Bissig4Adriana Baserga5Antonella Robatto6Lorenzo Magenta7Rossella Forlenza8Andreas Cerny9Fondazione Epatocentro Ticino, 6900 Lugano, SwitzerlandFondazione Epatocentro Ticino, 6900 Lugano, SwitzerlandCompetence Centre for Healthcare Practices and Policies, Department of Business Economics, Health and Social Care, University of Applied Sciences and Arts of Southern Switzerland, 6928 Manno, SwitzerlandFondazione Epatocentro Ticino, 6900 Lugano, SwitzerlandFondazione Epatocentro Ticino, 6900 Lugano, SwitzerlandFondazione Epatocentro Ticino, 6900 Lugano, SwitzerlandFondazione Epatocentro Ticino, 6900 Lugano, SwitzerlandFondazione Epatocentro Ticino, 6900 Lugano, SwitzerlandFondazione Epatocentro Ticino, 6900 Lugano, SwitzerlandFondazione Epatocentro Ticino, 6900 Lugano, SwitzerlandThe SARS-CoV-2 pandemic has revolutionized the scientific and medical world in recent years. Methylene blue (MB) is a well-known molecule. The aim of our study was to assess the efficacy of MB against early-phase SARS-CoV-2 infections. All patients with a positive swab for SARS-CoV-2 were eligible for the trial. The intervention was a starting dose of 200 mg MB or placebo in the morning and 100 mg in the evening on the first day and afterwards the standard daily dose of 200 mg. Patients were followed up for safety and efficacy until day 84. We analyzed 21 patients for the safety profile and 19 for the efficacy objective: of these, there were 11 in the MB group and 8 in the placebo one. In both groups, patients had undetectable RNA from day 3 and 10 out of 11 subjects in the MB group were virus free by day 12 vs. 6 out of 8 in the placebo one. None of the patients experienced serious adverse events. MB has proved to be a safe and well-tolerated drug. We did not find superiority of efficacy or viral clearance of MB compared to the placebo. Given the good in vitro efficacy, larger studies are needed to assess MB efficacy against COVID-19 in vivo.https://www.mdpi.com/2218-0532/92/4/56methylene blue 2COVID-19 3 SARS-CoV-2 |
| spellingShingle | Beatrice Barda Bruno Di Mari Emiliano Soldini Claudia Di Bartolomeo Maurizia Bissig Adriana Baserga Antonella Robatto Lorenzo Magenta Rossella Forlenza Andreas Cerny Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV-2-Affected Patients: A Proof-of-Concept Phase 2, Randomized, Placebo-Controlled, Single-Blind Clinical Trial Scientia Pharmaceutica methylene blue 2 COVID-19 3 SARS-CoV-2 |
| title | Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV-2-Affected Patients: A Proof-of-Concept Phase 2, Randomized, Placebo-Controlled, Single-Blind Clinical Trial |
| title_full | Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV-2-Affected Patients: A Proof-of-Concept Phase 2, Randomized, Placebo-Controlled, Single-Blind Clinical Trial |
| title_fullStr | Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV-2-Affected Patients: A Proof-of-Concept Phase 2, Randomized, Placebo-Controlled, Single-Blind Clinical Trial |
| title_full_unstemmed | Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV-2-Affected Patients: A Proof-of-Concept Phase 2, Randomized, Placebo-Controlled, Single-Blind Clinical Trial |
| title_short | Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV-2-Affected Patients: A Proof-of-Concept Phase 2, Randomized, Placebo-Controlled, Single-Blind Clinical Trial |
| title_sort | evaluation of the efficacy of methylene blue administration in sars cov 2 affected patients a proof of concept phase 2 randomized placebo controlled single blind clinical trial |
| topic | methylene blue 2 COVID-19 3 SARS-CoV-2 |
| url | https://www.mdpi.com/2218-0532/92/4/56 |
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