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Trial - NCT04619290


Column Value
Trial registration number NCT04619290
Full text link
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04619290

First author
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Martha E. Rodríguez Arellano, MD

Contact
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

marthaeunicer@yahoo.com.mx

Registration date
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-11-06

Recruitment status
Last imported at : Nov. 7, 2022, noon
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

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

single-center

Study aim
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - patients over 18 years of age - of both sexes - confirmed case of covid-19 (by rt-pcr) and ct less than 32 in the e - that they go to the er service due to covid symptoms, and that they voluntarily agree to participate in the study by written the informed consent - with at least 1 of the following symptoms: fever, headache, nausea, dyspnea, myalgia, vomiting, or diarrhea - with chest x-ray without pneumonia criteria - with so2> 90 - no history of allergic reaction to methylene blue - no history of treatment with medication with methylene blue negative interaction

Exclusion criteria
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- pregnancy and breastfeeding - preadmission anticoagulation - severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73m2) - active chronic hepatitis - patients with history of allergic reaction or significant sensitivity to methylene blue - treatment with immunosuppressive agents - diagnosis of cancer at any stage and of any type. - pregnancy and breastfeeding - patients who plan to become pregnant during the study period or within 6 months after the end of the study period. - participation in another clinical trial with an experimental drug in the last 30 days. - other pathologies that, in the medical opinion, contraindicate participation in the study. - uncompensated comorbidities

Number of arms
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Hospital Reg. Lic. Adolfo Lopez Mateos

Inclusion age min
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mexico

Type of patients
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

46

primary outcome
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Change form baseline in Arterial oxygen saturation;Days to clinical improvement

Notes
Last imported at : Nov. 7, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : Nov. 7, 2020, 11:31 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": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]