Methylene Blue for Treatment of Hospitalized COVID-19 Patients, Randomized, Controlled, Open-Label Clinical Trial, Phase 3

Daryoush  Hamidi Alamdari; Saied  Hafizi Lotfabadi; Behzad  Mavaji Darban; Marzieh  Agheli-Rad; Shahin  Saadatian; Seyed Hadi  Hashemi; Fatemeh  Barazandeh Ahmadabadi; Negar  Morovatdar; Mohammad Arastoo; Bharat Bhushan

Methylene Blue for Treatment of Hospitalized COVID-19 Patients, Randomized, Controlled, Open-Label Clinical Trial, Phase 3

Daryoush Hamidi Alamdari^* (Corresponding Author), Saied Hafizi Lotfabadi, Behzad Mavaji Darban, Marzieh Agheli-Rad, Shahin Saadatian, Seyed Hadi Hashemi, Fatemeh Barazandeh Ahmadabadi, Negar Morovatdar, Mohammad Arastoo, Bharat Bhushan

^*Corresponding author for this work

Institute of Medical Sciences

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Abstract

Background: Methylene blue (MB) possesses all the required properties for the clinical management of COVID-19. We have coined methylene blue as an anti-hypoxemia and anti-respiratory distress agent and previously witnessed promising results in phase 1 &2 clinical trials. Methods: In the phase 3 clinical trial, the efficacy of MB has been evaluated as an adjunct therapy along with standard care protocols in the treatment of COVID-19 patients. A randomized, controlled, open-label clinical trial was conducted from 20September through to 20 November 2020, and two hundred twenty-three hospitalized patients with confirmed severe cases of COVID-19 were recruited. Patients were randomly assigned to receive either oral MB (the reduced form: 1mg/kg T.I.D. for 2-days, followed by 1mg/kg B.I.D. for the next 12 days) along with standard care (MB group: 106) or standard care alone (SC-group: 117). The outcomes were duration of hospital stay and mortality. Results: The hospital stay, measured in days, was significantly shortened in the MB group (6.2 ± 3.1) in comparison to the SC-group (10.6 ± 9.2, p<0.001), and a marginal significant decrease in mortality was seen in the MB-group (12.2%) in comparison to SC-group (21.4%, p= 0.07). Conclusions: We conclude that MB, as an adjunct therapy, can be used along with standard care protocols for the treatment of COVID-19. Larger studies in other centers are needed to confirm these findings. MB is a low-cost and FDA-approved drug for methemoglobinemia.

Original language	English
Pages (from-to)	12-18
Number of pages	7
Journal	Aristotle Biomedical Journal
Volume	3
Issue number	2
Early online date	1 Dec 2021
Publication status	Published - 2021

Bibliographical note

Funding: This work was supported by a grant from Mashhad University of Medical Sciences (Grant number: 990096, 990845).
Acknowledgements: The authors gratefully acknowledge the nurses in Iamm Reza Hospital, Shariati Hospital, Hasheminejad Hospital for their excellent cooperation.

Data Availability Statement

Data is available on request through the authors and permission of the ethical committee of the university. If any physician desires to run a randomized clinical trial as part of a multicenter trial, the authors are keen to share their experiences and provide latest updates of their information.

Keywords

COVID-19
Treatment
Methylene Blue
Mortality

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Hamidi Alamdari, D., Hafizi Lotfabadi, S., Mavaji Darban, B., Agheli-Rad, M., Saadatian, S., Hashemi, S. H., Barazandeh Ahmadabadi, F., Morovatdar, N., Arastoo, M., & Bhushan, B. (2021). Methylene Blue for Treatment of Hospitalized COVID-19 Patients, Randomized, Controlled, Open-Label Clinical Trial, Phase 3. Aristotle Biomedical Journal, 3(2), 12-18. https://ejournals.lib.auth.gr/ABJ/article/view/8158/7922

Hamidi Alamdari, D, Hafizi Lotfabadi, S, Mavaji Darban, B, Agheli-Rad, M, Saadatian, S, Hashemi, SH, Barazandeh Ahmadabadi, F, Morovatdar, N, Arastoo, M & Bhushan, B 2021, 'Methylene Blue for Treatment of Hospitalized COVID-19 Patients, Randomized, Controlled, Open-Label Clinical Trial, Phase 3', Aristotle Biomedical Journal, vol. 3, no. 2, pp. 12-18. <https://ejournals.lib.auth.gr/ABJ/article/view/8158/7922>

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title = "Methylene Blue for Treatment of Hospitalized COVID-19 Patients, Randomized, Controlled, Open-Label Clinical Trial, Phase 3",

abstract = "Background: Methylene blue (MB) possesses all the required properties for the clinical management of COVID-19. We have coined methylene blue as an anti-hypoxemia and anti-respiratory distress agent and previously witnessed promising results in phase 1 &2 clinical trials. Methods: In the phase 3 clinical trial, the efficacy of MB has been evaluated as an adjunct therapy along with standard care protocols in the treatment of COVID-19 patients. A randomized, controlled, open-label clinical trial was conducted from 20September through to 20 November 2020, and two hundred twenty-three hospitalized patients with confirmed severe cases of COVID-19 were recruited. Patients were randomly assigned to receive either oral MB (the reduced form: 1mg/kg T.I.D. for 2-days, followed by 1mg/kg B.I.D. for the next 12 days) along with standard care (MB group: 106) or standard care alone (SC-group: 117). The outcomes were duration of hospital stay and mortality. Results: The hospital stay, measured in days, was significantly shortened in the MB group (6.2 ± 3.1) in comparison to the SC-group (10.6 ± 9.2, p<0.001), and a marginal significant decrease in mortality was seen in the MB-group (12.2%) in comparison to SC-group (21.4%, p= 0.07). Conclusions: We conclude that MB, as an adjunct therapy, can be used along with standard care protocols for the treatment of COVID-19. Larger studies in other centers are needed to confirm these findings. MB is a low-cost and FDA-approved drug for methemoglobinemia.",

keywords = "COVID-19, Treatment, Methylene Blue, Mortality",

author = "{Hamidi Alamdari}, Daryoush and {Hafizi Lotfabadi}, Saied and {Mavaji Darban}, Behzad and Marzieh Agheli-Rad and Shahin Saadatian and Hashemi, {Seyed Hadi} and {Barazandeh Ahmadabadi}, Fatemeh and Negar Morovatdar and Mohammad Arastoo and Bharat Bhushan",

note = "Funding: This work was supported by a grant from Mashhad University of Medical Sciences (Grant number: 990096, 990845). Acknowledgements: The authors gratefully acknowledge the nurses in Iamm Reza Hospital, Shariati Hospital, Hasheminejad Hospital for their excellent cooperation.",

year = "2021",

language = "English",

volume = "3",

pages = "12--18",

journal = "Aristotle Biomedical Journal",

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T1 - Methylene Blue for Treatment of Hospitalized COVID-19 Patients, Randomized, Controlled, Open-Label Clinical Trial, Phase 3

AU - Hamidi Alamdari, Daryoush

AU - Hafizi Lotfabadi, Saied

AU - Mavaji Darban, Behzad

AU - Agheli-Rad, Marzieh

AU - Saadatian, Shahin

AU - Hashemi, Seyed Hadi

AU - Barazandeh Ahmadabadi, Fatemeh

AU - Morovatdar, Negar

AU - Arastoo, Mohammad

AU - Bhushan, Bharat

N1 - Funding: This work was supported by a grant from Mashhad University of Medical Sciences (Grant number: 990096, 990845). Acknowledgements: The authors gratefully acknowledge the nurses in Iamm Reza Hospital, Shariati Hospital, Hasheminejad Hospital for their excellent cooperation.

PY - 2021

Y1 - 2021

N2 - Background: Methylene blue (MB) possesses all the required properties for the clinical management of COVID-19. We have coined methylene blue as an anti-hypoxemia and anti-respiratory distress agent and previously witnessed promising results in phase 1 &2 clinical trials. Methods: In the phase 3 clinical trial, the efficacy of MB has been evaluated as an adjunct therapy along with standard care protocols in the treatment of COVID-19 patients. A randomized, controlled, open-label clinical trial was conducted from 20September through to 20 November 2020, and two hundred twenty-three hospitalized patients with confirmed severe cases of COVID-19 were recruited. Patients were randomly assigned to receive either oral MB (the reduced form: 1mg/kg T.I.D. for 2-days, followed by 1mg/kg B.I.D. for the next 12 days) along with standard care (MB group: 106) or standard care alone (SC-group: 117). The outcomes were duration of hospital stay and mortality. Results: The hospital stay, measured in days, was significantly shortened in the MB group (6.2 ± 3.1) in comparison to the SC-group (10.6 ± 9.2, p<0.001), and a marginal significant decrease in mortality was seen in the MB-group (12.2%) in comparison to SC-group (21.4%, p= 0.07). Conclusions: We conclude that MB, as an adjunct therapy, can be used along with standard care protocols for the treatment of COVID-19. Larger studies in other centers are needed to confirm these findings. MB is a low-cost and FDA-approved drug for methemoglobinemia.

AB - Background: Methylene blue (MB) possesses all the required properties for the clinical management of COVID-19. We have coined methylene blue as an anti-hypoxemia and anti-respiratory distress agent and previously witnessed promising results in phase 1 &2 clinical trials. Methods: In the phase 3 clinical trial, the efficacy of MB has been evaluated as an adjunct therapy along with standard care protocols in the treatment of COVID-19 patients. A randomized, controlled, open-label clinical trial was conducted from 20September through to 20 November 2020, and two hundred twenty-three hospitalized patients with confirmed severe cases of COVID-19 were recruited. Patients were randomly assigned to receive either oral MB (the reduced form: 1mg/kg T.I.D. for 2-days, followed by 1mg/kg B.I.D. for the next 12 days) along with standard care (MB group: 106) or standard care alone (SC-group: 117). The outcomes were duration of hospital stay and mortality. Results: The hospital stay, measured in days, was significantly shortened in the MB group (6.2 ± 3.1) in comparison to the SC-group (10.6 ± 9.2, p<0.001), and a marginal significant decrease in mortality was seen in the MB-group (12.2%) in comparison to SC-group (21.4%, p= 0.07). Conclusions: We conclude that MB, as an adjunct therapy, can be used along with standard care protocols for the treatment of COVID-19. Larger studies in other centers are needed to confirm these findings. MB is a low-cost and FDA-approved drug for methemoglobinemia.

KW - COVID-19

KW - Treatment

KW - Methylene Blue

KW - Mortality

M3 - Article

SN - 2653-9748

VL - 3

SP - 12

EP - 18

JO - Aristotle Biomedical Journal

JF - Aristotle Biomedical Journal

IS - 2

ER -

Methylene Blue for Treatment of Hospitalized COVID-19 Patients, Randomized, Controlled, Open-Label Clinical Trial, Phase 3

Abstract

Bibliographical note

Data Availability Statement

Keywords

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