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
Abstract
:1. Introduction
2. Materials and Methods
2.1. Design of the Study
2.2. Clinical Trial Schedule
2.3. Statistical Analysis
3. Results
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Conflicts of Interest
References
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Methylene Blue Group (n = 15) | Placebo Group (n = 14) | Statistical Test Result | |
---|---|---|---|
Gender | |||
Woman | 8 | 8 | χ2(1) = 0.909 |
Man | 7 | 9 | |
Age | |||
Median (IQR) | 50.0 (21.0) | 46.5 (18.3) | z = 0.481 |
Body mass index | |||
Median (IQR) | 26.8 (6.5) | 26.0 (9.1) | z = 0.349 |
Ethnicity | |||
White | 14 | 14 | χ2(1) = 0.007 |
Asian | 1 | 0 |
Symptom | Methylene Blue Group (n = 11) | Placebo Group (n = 8) | Statistical Test Result |
---|---|---|---|
Fever | 9 | 4 | χ2(1) = 2.89 * |
Cough | 9 | 10 | χ2(1) = 0.41 |
Fatigue | 13 | 9 | χ2(1) = 1.981 |
Nasal congestion | 11 | 6 | χ2(1) = 2.77 * |
Smell alteration | 5 | 3 | χ2(1) = 0.51 |
Taste alteration | 7 | 4 | χ2(1) = 1.00 |
Dyspnoea | 3 | 4 | χ2(1) = 0.29 |
Conjunctivitis | 0 | 1 | χ2(1) = 1.11 |
Diarrhea | 4 | 4 | χ2(1) = 0.01 |
Muscular exertion | 8 | 6 | χ2(1) = 0.31 |
Area under the Curve (AUC) | Group | Difference | 95% Confidence Interval of Difference | t-Statistic | |
---|---|---|---|---|---|
Methylene Blue | Placebo | ||||
AUC Mean (SD 1) | 5.1 (5.2) | 3.4 (3.0) | 1.70 2 | (−2.10,5.50) | 0.94 |
AUC Median (Min;Max) | 3.5 (0.0;12.6) | 2.6 (0.0;6.8) | 0.88 3 | (−2.59,6.10) 3 | - |
AUC for 2^DCt expressed as % from baseline [Median (Min;Max)] | 271 (121;820) | 125 (100;436) | - | - | - |
Efficacy Endpoints | Group | Statistical Test Result | ||
---|---|---|---|---|
Methylene Blue (n = 11) | Placebo (n = 8) | |||
Virus clearance after 3 days | Yes | 2 | 1 | χ2(1) = 0.115 |
Virus clearance after 6 days | Yes | 4 | 2 | χ2(1) = 0.281 |
Virus clearance after 9 days | Yes | 9 | 4 | χ2(1) = 2.170 |
Virus clearance after 12 days | Yes | 10 | 6 | χ2(1) = 0.882 |
Virus clearance after 15 days | Yes | 8 | 6 | χ2(1) = 0.012 |
Virus clearance after 21 days | Yes | 11 | 8 | No test performed |
Viral load reduction of at least 2 log by day 3 | Yes | 0 | 1 | χ2(2) = 2.847 |
No | 9 | 7 | ||
VCW2LR 2 | 2 | 0 |
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© 2024 by the authors. Published by MDPI on behalf of the Österreichische Pharmazeutische Gesellschaft. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
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Barda, B.; Di Mari, B.; Soldini, E.; Di Bartolomeo, C.; Bissig, M.; Baserga, A.; Robatto, A.; Magenta, L.; Forlenza, R.; Cerny, A. 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. Sci. Pharm. 2024, 92, 56. https://doi.org/10.3390/scipharm92040056
Barda B, Di Mari B, Soldini E, Di Bartolomeo C, Bissig M, Baserga A, Robatto A, Magenta L, Forlenza R, Cerny A. 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. 2024; 92(4):56. https://doi.org/10.3390/scipharm92040056
Chicago/Turabian StyleBarda, Beatrice, Bruno Di Mari, Emiliano Soldini, Claudia Di Bartolomeo, Maurizia Bissig, Adriana Baserga, Antonella Robatto, Lorenzo Magenta, Rossella Forlenza, and Andreas Cerny. 2024. "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 92, no. 4: 56. https://doi.org/10.3390/scipharm92040056