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Trial - NCT04760821


Column Value
Trial registration number NCT04760821
Full text link
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04760821

First author
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Luis Henrique Wolff Gowdak, MD, PhD

Contact
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

luis.gowdak@gmail.com

Registration date
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-18

Recruitment status
Last imported at : Feb. 3, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 20, 2021, 12:31 a.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 : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

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

a. inclusion criteria: clinical diagnosis of moderate to severe acute respiratory syndrome due to sars-cov2 defined as: 1.1. tachypnea: > 24 breaths per minute 1.2. hypoxemia: arterial oxygen saturation <94% in room air by pulse oximetry 1.3. presumptive (or confirmed) diagnosis of sars-cov2 infection by at least one of the following criteria: polymerase chain reaction assay (+) for sars-cov2 serology (+) for sars-cov2 sars-cov2 antigen diagnostic tests (+) chest ct with findings suggestive of the diagnosis of covid-19 in the presence of medical history or clinical signs compatible with the diagnosis of covid-19 signature of the informed consent form b.

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

chronic renal dysfunction stage 4 (gfr <30ml / min / 1.73m2 calculated by the chronic kidney disease epidemiology collaboration (ckd-epi) equation patient on renal replacement therapy by dialysis pregnant and lactating women previous use of trimetazidine less than two weeks before hospital admission any clinical condition at the investigator´s discretion likely to be associated with elevation of baseline hs-troponin >99th percentile

Number of arms
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Ministry of Health, Brazil

Inclusion age min
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Brazil

Type of patients
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

80

primary outcome
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

High-sensitivity cardiac troponin

Notes
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Phase 2

Arms
Last imported at : Feb. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "", "treatment_id": 1318, "treatment_name": "Trimetazidine", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}]