Covid19
Conditions
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.
Interventions
DRUGMethylene Blue
MB administered topically as a 0.02% solution nasal spray in COVID-19 patients requiring hospitalization.
Saline administered topically as nasal spray in COVID-19 patients requiring hospitalization.
Sponsors
Irkutsk State Medical University
Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Randomization by phone
Intervention model description
Single-center, blind, randomized, controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery | Day 14 after randomization | A negative PCR test result for the SARS-CoV-2 using nasopharyngeal and oropharyngeal swabs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall therapeutic response FUV | Follow up visit, week 4 ± 3 days after discharge from the hospital | 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. |
| Clinical responce | Day 28 after randomization | Determined by the investigator |
| Overall therapeutic response | Day 28 after randomization | 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 | Day 28 after randomization | The rate of resolution of fever, normalization of SpO2 (NEWS2), dynamics of target laboratory parameters (C-reactive protein, D-dimer) |
| Clinical responce FUV | Follow up visit, week 4 ± 3 days after discharge from the hospital | Determined by the investigator |
Countries
Russia
Outcome results
None listed