COVID-19 Methylene Blue Antiviral Treatment

NCT ID: NCT05004805

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-06
• Study Completion Date: 2021-12-12

Brief Summary

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.

Detailed Description

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Methylene blue Arm

The intervention is carried out in addition to the standard treatment. Administered Intervention is topical application of 0.02% Methylene blue solution in the form of repeated nasopharyngeal irrigation. The investigational drug is equipped with a spray nozzle to perform three administrations into both lower nasal passages. After three administrations on each side, it is recommended to take a deep breath so that the injected solution is distributed along the nasopharynx and oropharynx every 4 hours (5-6 times a day with a break for sleep). Duration is the period of stay of the subject, as long as there is no need for non-invasive or invasive mechanical ventilation. If the subject refuses further treatment in a hospital but does not withdraw consent to participate in the study, they should continue to take study drug after discharge from hospital, but not later than the date of the follow-up visit.

Group Type: EXPERIMENTAL

Methylene Blue

Intervention Type: DRUG

MB administered topically as a 0.02% solution nasal spray in COVID-19 patients requiring hospitalization.

Saline solution Arm

The intervention is carried out in addition to the standard treatment. Adminestered Intervention is saline solution in the form of repeated nasopharyngeal irrigation. Dosage form, dosage, frequency and duration of intervention are the same.

Group Type: PLACEBO_COMPARATOR

Saline nasal spray

Intervention Type: DRUG

Saline administered topically as nasal spray in COVID-19 patients requiring hospitalization.

Interventions

Methylene Blue

MB administered topically as a 0.02% solution nasal spray in COVID-19 patients requiring hospitalization.

Intervention Type: DRUG

Saline nasal spray

Saline administered topically as nasal spray in COVID-19 patients requiring hospitalization.

Intervention Type: DRUG

Other Intervention Names

MB Spray; Placebo Spray

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Irkutsk State Medical University

OTHER

Sponsor Role: collaborator

Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Irkutsk Regional Hospital

Irkutsk, Irkutsk Oblast, Russia

Countries

Russia

Other Identifiers

COMBAT

Identifier Type: -

Identifier Source: org_study_id