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Trial - NCT05004805


Column Value
Trial registration number NCT05004805
Full text link
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05004805

First author
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov

Konstantin Apartsin, Professor

Contact
Last imported at : Oct. 14, 2021, 2:24 p.m.
Source : ClinicalTrials.gov

director@isc.irk.ru

Registration date
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

2021-08-13

Recruitment status
Last imported at : Feb. 11, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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.

Number of arms
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences

Inclusion age min
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Russia

Type of patients
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

24

primary outcome
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Recovery;Recovery

Notes
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Aug. 14, 2021, 5 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 797, "treatment_name": "Methylene blue", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]