Covid19 Clinical Trial
— COMBATOfficial title:
COVID-19 Methylene Blue Antiviral Treatment
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.
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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Irkutsk Regional Hospital | Irkutsk | Irkutskaya Oblast |
Lead Sponsor | Collaborator |
---|---|
Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences | Irkutsk State Medical University |
Russian Federation,
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 |
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