COVID-19 Methylene Blue Antiviral Treatment

NCT05004805 | Completed Phase 2

• 1 other identifier: COMBAT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• Recovery

  A negative PCR test result for the SARS-CoV-2 using nasopharyngeal and oropharyngeal swabs

  Day 14 after randomization

• Recovery

  A negative PCR test result for the SARS-CoV-2 using nasopharyngeal and oropharyngeal swabs

  Day 28 after randomization

Secondary Outcomes (5)

• Clinical responce

  Day 28 after randomization

• Overall therapeutic response

  Day 28 after randomization

• Resolution rate

  Day 28 after randomization

• Clinical responce FUV

  Follow up visit, week 4 ± 3 days after discharge from the hospital

• Overall therapeutic response FUV

  Follow up visit, week 4 ± 3 days after discharge from the hospital

Study Arms (2)

Methylene blue Arm

EXPERIMENTAL

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.

Drug: Methylene Blue

Saline solution Arm

PLACEBO COMPARATOR

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.

Drug: Saline nasal spray

Interventions

Methylene Blue DRUG

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

Also known as: MB Spray

Methylene blue Arm

Saline nasal spray DRUG

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

Also known as: Placebo Spray

Saline solution Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 and over at the time of signing the informed consent.
• The patient is willing and able to give written informed consent to participate in the study and follow the procedures specified in the protocol.
• Diagnosed with COVID-19, confirmed by a PCR test positive for the SARS-CoV-2 coronavirus in smears from the nasopharynx and oropharynx.
• 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.
• A urine test performed during screening, negative for pregnancy in women capable of childbearing.

You may not qualify if:

• 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.
• 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.).
• Topical or systemic use of Methylene blue for any reasons at the time of evaluation or during the interval of 30 days before hospitalization.
• Known intolerance or hypersensitivity to Methylene blue (indicated in the medical history of the patient).
• Patients with a high probability of not surviving within the first 24 h of hospitalization, regardless of the treatment, as defined by the investigator.

Sponsors & Collaborators

• Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences: lead
• Irkutsk State Medical University: collaborator

Study Sites (1)

Irkutsk Regional Hospital

Irkutsk, Irkutsk Oblast, 664049, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization by phone
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single-center, blind, randomized, controlled clinical trial.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 13, 2021
• Study Start: August 6, 2021
• Primary Completion: December 12, 2021
• Study Completion: December 12, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

RU (1)