METHYLENE BLUE FOR TREATMENT OF HOSPITALIZED COVID-19 PATIENTS: A RANDOMIZED, CONTROLLED, OPEN-LABEL CLINICAL TRIAL, PHASE 2.

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 (SpO) 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 SpO and RR on the 3 and 5 days. The secondary outcomes were hospital stay and mortality within 28 days.

RESULTS

In the MB group, a significant improvement in SpO and RR was observed on the 3 day (for both, p < 0.0001) and also the 5 day (for both, p < 0.0001). In the SOC group, there was no significant improvement in SpO (p = 0.24) and RR (p = 0.20) on the 3 day, although there was a significant improvement of SpO (p = 0.002) and RR (p = 0.01) on the 5 day. In the MB group in comparison to the SOC group, the rate ratio of increased SpO was 13.5 and 2.1 times on the 3 and 5 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 3 and 5 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 SpO and respiratory distress in COVID-19 patients, which resulted in decreased hospital stay and mortality. ClinicalTrials.gov: NCT04370288.