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


  • COVID-19
  • Treatment
  • Methylene Blue
  • Mortality


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