TY - JOUR
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
VL - 3
SP - 12
EP - 18
JO - Aristotle Biomedical Journal
JF - Aristotle Biomedical Journal
SN - 2653-9748
IS - 2
ER -