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 20
September 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 (MBgroup: 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 MBgroup (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
|Number of pages||7|
|Journal||Aristotle Biomedical Journal|
|Publication status||Published - 2021|
- Methylene Blue