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Trial - NCT04933864


Column Value
Trial registration number NCT04933864
Full text link
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04933864

First author
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

Igor V. Reshetov

Contact
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

2021-06-22

Recruitment status
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - signed informed consent - age: 18-90 years - positive quantitative polymerase chain reaction test on sars-cov-2 infection - negative pregnancy test in women - any severity of pneumonia (computer tomography scans) non-inclusion criteria: - documented refusal to participate in the study - treatment with a serotonergic drug - connection to artificial lung ventilation with or without sedation - history of g-6-phosphatase deficiency - pregnancy and breastfeeding - medical records of cirrhosis - active chronic hepatitis

Exclusion criteria
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

- myocardial infarction, developed after the patient was included in the study, but before the intervention - bleeding, developed after the patient was included in the study, but before the intervention - connection to artificial lung ventilation developed after the patient was included in the study, but before the intervention

Number of arms
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

I.M. Sechenov First Moscow State Medical University

Inclusion age min
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

90

Countries
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

Russia

Type of patients
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

No restriction on type of patients

Severity scale
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

0: No restriction on type of patients

Total sample size
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

60

primary outcome
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

The percentage of participants with negative quantitative Polymerase Chain Reaction test on SARS-CoV-2 on day 2 after methylene blue administration and photodynamic therapy

Notes
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1629, "treatment_name": "Methylene blue+photodynamic", "treatment_type": "Others pharmacological treatment+medical device", "pharmacological_treatment": "Pharmacological treatment+non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]