This is a pilot study of a single-center, blind, randomized, placebo-controlled, parallel-group study testing for the efficacy and safety of Methylene blue when administered topically as a 0.02% solution for nasopharyngeal and oropharyngeal irrigation in COVID-19 patients requiring hospitalization.
Purpose of the study. To test the hypothesis that the topical application of 0.02% MB
solution in the form of repeated nasopharyngeal irrigation will lead to an accelerated
recovery compared to placebo, defined by the clinical, laboratory, and radiological
improvement with a negative molecular test for SARS-CoV-2 by polymerase chain reaction (PCR).
The main objective of the study is to demonstrate the effectiveness of 0.02% MB irrigation of
the nasopharynx mucosa over placebo, alongside the standard treatment carried out in
accordance with the Temporary Guidelines of "Prevention, Diagnosis, and Treatment of Novel
Coronavirus Infection (COVID-19)", version 11 (May 7, 2021). Regarding the recovery of
patients with COVID-19, this is defined as a negative PCR test result for the SARS-CoV-2
coronavirus in swabs from the nasopharynx and oropharynx on the 14th and 28th day after
initiation of the experimental treatment.
A secondary objective of this study is to evaluate the additional efficacy and overall safety
parameters, including saturation dynamics, C-reactive protein, D-dimer, CT signs of lung
damage, dynamics of the National Early Warning Score (NEWS) 2 during treatment. Due to the
pilot nature of this study, another goal is to calculate the effect based on the number of
subjects per group for a future study.
Drug: Methylene Blue
MB administered topically as a 0.02% solution nasal spray in COVID-19 patients requiring hospitalization.
Other Name: MB Spray
Drug: Saline nasal spray
Saline administered topically as nasal spray in COVID-19 patients requiring hospitalization.
Other Name: Placebo Spray
Inclusion Criteria:
1. Men and women aged 18 and over at the time of signing the informed consent.
2. The patient is willing and able to give written informed consent to participate in the
study and follow the procedures specified in the protocol.
3. Diagnosed with COVID-19, confirmed by a PCR test positive for the SARS-CoV-2
coronavirus in smears from the nasopharynx and oropharynx.
4. Indications for hospitalization for COVID-19 treatment: a moderate condition that does
not require oxygen support or low oxygen flow required through a nasal cannula or
oxygen mask.
5. A urine test performed during screening, negative for pregnancy in women capable of
childbearing.
Exclusion Criteria:
1. The need for non-invasive ventilation or high oxygen flow, or intubation of the
trachea with artificial ventilation, or the use of vasopressors and/or extracorporeal
membrane oxygenation at the time of assessment.
2. Decompensation of concomitant pathology, whose severity exceeds the severity of
COVID-19 manifestations (for example, acute coronary syndrome, cerebral circulation
disorders, acute surgical pathology requiring surgical intervention, bleeding
independent of the localization, etc.).
3. Topical or systemic use of Methylene blue for any reasons at the time of evaluation or
during the interval of 30 days before hospitalization.
4. Known intolerance or hypersensitivity to Methylene blue (indicated in the medical
history of the patient).
5. Patients with a high probability of not surviving within the first 24 h of
hospitalization, regardless of the treatment, as defined by the investigator.
Irkutsk Regional Hospital
Irkutsk, Irkutskaya Oblast, Russian Federation