Methylene blue for treatment of hospitalized COVID-19 patients: a randomized, controlled, open-label clinical trial, phase 2
Hamidi-Alamdari et al.,
Methylene blue for treatment of hospitalized COVID-19 patients: a randomized, controlled, open-label clinical..,
Clinical and Translational Investigation, doi:10.24875/RIC.21000028, NCT04370288
RCT 80 hospitalized patients with severe COVID-19, 40 treated with methylene blue + vitamin C + N-acetylcysteine, showing lower mortality, shorter hospitalization, and significantly improved SpO
2 and respiratory distress with treatment.
NCT04370288 (history).
risk of death, 44.4% lower, RR 0.56, p = 0.38, treatment 5 of 40 (12.5%), control 9 of 40 (22.5%), NNT 10.0.
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hospitalization time, 37.6% lower, relative time 0.62, p = 0.004, treatment 40, control 40.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Hamidi-Alamdari et al., 8 Mar 2021, Randomized Controlled Trial, Iran, peer-reviewed, 23 authors, this trial uses multiple treatments in the treatment arm (combined with methylene blue and N-acetyl cysteine) - results of individual treatments may vary, trial
NCT04370288 (history).
Abstract: REVISTA DE INVESTIGACIÓN CLÍNICA
Contents available at PubMed
www.clinicalandtranslationalinvestigation.com
Rev Invest Clin. 2021;73(3):190-8
ORIGINAL ARTICLE
Methylene Blue for Treatment
of Hospitalized COVID-19 Patients:
A Randomized, Controlled,
Open-Label Clinical Trial, Phase 2
Daryoush Hamidi-Alamdari1*, Saied Hafizi-Lotfabadi2, Ahmad Bagheri-Moghaddam3,
Hossin Safari4, Mahnaz Mozdourian5, Zahra Javidarabshahi5, Arash Peivandi-Yazdi5,
Abass Ali-Zeraati6, Alireza Sedaghat5, Farid Poursadegh5, Fatemeh Barazandeh-Ahmadabadi2,
Marzieh Agheli-Rad2, Seyed M. Tavousi6, Shohreh Vojouhi7, Shahram Amini8, Mahnaz Amini5,
Seyed Majid-Hosseini9, Ashraf Tavanaee-Sani10, Amin Ghiabi11, Shima Nabavi-Mahalli9,
Negar Morovatdar12, Omid Rajabi13, and George Koliakos14
1Surgical Oncology Research Center; 2Department of Internal Medicine, Shariati Hospital; 3Department of
Anesthesiology, Faculty of Medicine; 4Infectious Diseases Ward, Hasheminejad Hospital; 5Lung Diseases Research
Center; 6Kidney Transplantation Complications Research Center, Faculty of Medicine; 7Metabolic Syndrome
Research Center, School of Medicine; 8Anaesthesiology and Critical Care Lung Research Center, Faculty of Medicine;
9Department of Internal Medicine, Emamreza Hospital; 10Department of Infectious diseases, Emamreza Hospital;
11Department of Internal Medicine, Ghaem Hospital; 12Clinical Research Development Unit, Imam Reza Hospital,
Faculty of Medicine, and 13Department of Pharmaceutical Control, School of Pharmacy, Mashhad University of Medical
Sciences, Mashhad, Iran; 14Department of Biochemistry, Medical School, Aristotle University of Thessaloniki,
Thessaloniki, Greece
ABSTRACT
Background: There is no pharmacological intervention on the treatment of hypoxemia and respiratory distress in COVID-19
patients. Objective: The objective of the study was to study the effect of the reduced form of methylene blue (MB) on the
improvement of oxygen saturation (SpO2) and respiratory rate (RR). Methods: In an academic medical center, 80 hospitalized
patients with severe COVID-19 were randomly assigned to receive either oral MB along with standard of care (SOC) (MB group,
n = 40) or SOC only (SOC group, n=40). The primary outcomes were SpO2 and RR on the 3rd and 5th days. The secondary outcomes were hospital stay and mortality within 28 days. Results: In the MB group, a significant improvement in SpO2 and RR was
observed on the 3rd day (for both, p < 0.0001) and also the 5th day (for both, p < 0.0001). In the SOC group, there was no
significant improvement in SpO2 (p = 0.24) and RR (p = 0.20) on the 3rd day, although there was a significant improvement of
SpO2 (p = 0.002) and RR (p = 0.01) on the 5th day. In the MB group in comparison to the SOC group, the rate ratio of increased
SpO2 was 13.5 and 2.1 times on the 3rd and 5th days, respectively. In the MB group compared with the SOC group, the rate
ratio of RR improvement was 10.1 and 3.7 times on the 3rd and 5th days, respectively. The hospital stay was significantly shortened in the MB group (p = 0.004), and the mortality was 12.5% and 22.5% in the MB and SOC groups, respectively. Conclusions:
The addition of MB to the treatment protocols significantly improved SpO2 and respiratory distress in COVID-19 patients, which
resulted in decreased hospital stay and mortality. ClinicalTrials.gov: NCT04370288 (REV INVEST CLIN. 2021;73(3):XX-XX)
Key words: COVID-19. Treatment. Methylene Blue. Hypoxemia. Mortality.
*Corresponding..
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