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

Research output: Contribution to journalArticlepeer-review

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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 languageEnglish
Pages (from-to)12-18
Number of pages7
JournalAristotle Biomedical Journal
Issue number2
Early online date1 Dec 2021
Publication statusPublished - 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.


  • COVID-19
  • Treatment
  • Methylene Blue
  • Mortality


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