COVID-19 Methylene Blue Antiviral Treatment

Covid19 Clinical Trial

— COMBAT  

Official title:

COVID-19 Methylene Blue Antiviral Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05004805
• Other study ID #: COMBAT
• Status: Completed
• Phase: Phase 2
• Start date: August 6, 2021
• Est. completion date: December 12, 2021

Study information

• Verified date: February 2022
• Source: Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 12, 2021
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Methylene Blue
MB administered topically as a 0.02% solution nasal spray in COVID-19 patients requiring hospitalization.
• Saline nasal spray
Saline administered topically as nasal spray in COVID-19 patients requiring hospitalization.

Locations

Country	Name	City	State
Russian Federation	Irkutsk Regional Hospital	Irkutsk	Irkutskaya Oblast

Sponsors (2)

Lead Sponsor	Collaborator
Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences	Irkutsk State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery	A negative PCR test result for the SARS-CoV-2 using nasopharyngeal and oropharyngeal swabs	Day 14 after randomization
Primary	Recovery	A negative PCR test result for the SARS-CoV-2 using nasopharyngeal and oropharyngeal swabs	Day 28 after randomization
Secondary	Clinical responce	Determined by the investigator	Day 28 after randomization
Secondary	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.	Day 28 after randomization
Secondary	Resolution rate	The rate of resolution of fever, normalization of SpO2 (NEWS2), dynamics of target laboratory parameters (C-reactive protein, D-dimer)	Day 28 after randomization
Secondary	Clinical responce FUV	Determined by the investigator	Follow up visit, week 4 ± 3 days after discharge from the hospital
Secondary	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.	Follow up visit, week 4 ± 3 days after discharge from the hospital