Back to resultsCOVID-19 Methylene Blue Antiviral Treatment (COMBAT)
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Methylene Blue
Saline nasal spray
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Irkutsk Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Methylene blue Arm
Saline solution Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Recovery
A negative PCR test result for the SARS-CoV-2 using nasopharyngeal and oropharyngeal swabs
Recovery
A negative PCR test result for the SARS-CoV-2 using nasopharyngeal and oropharyngeal swabs
Secondary Outcome Measures
Clinical responce
Determined by the investigator
Overall therapeutic response
The overall therapeutic response defined as a "general cure" or "treatment failure" and is calculated for each patient according to the patient's combination of clinical, radiological response, and PCR result.
Resolution rate
The rate of resolution of fever, normalization of SpO2 (NEWS2), dynamics of target laboratory parameters (C-reactive protein, D-dimer)
Clinical responce FUV
Determined by the investigator
Overall therapeutic response FUV
The overall therapeutic response defined as a "general cure" or "treatment failure" and is calculated for each patient according to the patient's combination of clinical, radiological response, and PCR result.
Full Information
NCT ID
NCT05004805
First Posted
August 11, 2021
Last Updated
February 8, 2022
Sponsor
Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences
Collaborators
Irkutsk State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05004805
Brief Title
COVID-19 Methylene Blue Antiviral Treatment
Acronym
COMBAT
Official Title
COVID-19 Methylene Blue Antiviral Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
December 12, 2021 (Actual)
Study Completion Date
December 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences
Collaborators
Irkutsk State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Single-center, blind, randomized, controlled clinical trial.
Masking
Outcomes Assessor
Masking Description
Randomization by phone
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylene blue Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline solution Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Other Intervention Name(s)
MB Spray
Intervention Description
MB administered topically as a 0.02% solution nasal spray in COVID-19 patients requiring hospitalization.
Intervention Type
Drug
Intervention Name(s)
Saline nasal spray
Other Intervention Name(s)
Placebo Spray
Intervention Description
Saline administered topically as nasal spray in COVID-19 patients requiring hospitalization.
Primary Outcome Measure Information:
Title
Recovery
Description
A negative PCR test result for the SARS-CoV-2 using nasopharyngeal and oropharyngeal swabs
Time Frame
Day 14 after randomization
Title
Recovery
Description
A negative PCR test result for the SARS-CoV-2 using nasopharyngeal and oropharyngeal swabs
Time Frame
Day 28 after randomization
Secondary Outcome Measure Information:
Title
Clinical responce
Description
Determined by the investigator
Time Frame
Day 28 after randomization
Title
Overall therapeutic response
Description
The overall therapeutic response defined as a "general cure" or "treatment failure" and is calculated for each patient according to the patient's combination of clinical, radiological response, and PCR result.
Time Frame
Day 28 after randomization
Title
Resolution rate
Description
The rate of resolution of fever, normalization of SpO2 (NEWS2), dynamics of target laboratory parameters (C-reactive protein, D-dimer)
Time Frame
Day 28 after randomization
Title
Clinical responce FUV
Description
Determined by the investigator
Time Frame
Follow up visit, week 4 ± 3 days after discharge from the hospital
Title
Overall therapeutic response FUV
Description
The overall therapeutic response defined as a "general cure" or "treatment failure" and is calculated for each patient according to the patient's combination of clinical, radiological response, and PCR result.
Time Frame
Follow up visit, week 4 ± 3 days after discharge from the hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Irkutsk Regional Hospital
City
Irkutsk
State/Province
Irkutskaya Oblast
ZIP/Postal Code
664049
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
COVID-19 Methylene Blue Antiviral Treatment
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