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临床试验/NCT04353245
NCT04353245Unknown不适用

Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System: Effect of Hydroxychloroquine / Azithromycin Combined Therapy

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
130
试验地点
1
主要终点
Fibrosis

研究概览

简要总结

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) poses a significant threat to global health. As the disease progresses, a series of acute complications tend to develop in multiple organs. Beyond the supportive care, no specific treatment has been established for COVID-19. The effectiveness, both short-term and long-term, of some promising antivirals, such as the hydroxychloroquine combination with azithromycin, needs to be evaluated. This study aims to investigate the predictive role of cardiac biomarkers and pulmonary symptoms for late complications of COVID-19 coronavirus infection on the heart and lung in patients treated with the hydroxychloroquine / azithromycin combination therapy. Thus, COVID-19 coronavirus patients undergoing hydroxychloroquine / azithromycin combination therapy will be compared to patients not undergoing this therapy. The comparison will be made by the analysis of the relationships between (1) levels of ultrasensitive cardiac troponins collected at the beginning of the infection and cardiac magnetic resonance data in the 3rd and 12th months of troponin collection and (2) findings CT scans and the results of the ergospirometers tests performed in those same periods. It is expected to demonstrate that: (1) cardiac troponin and lung tomographic findings can predict late complications of COVID-19 coronavirus infection in the heart and lung, assessed by cardiac magnetic resonance and ergospirometers one year after the beginning of the infection, and (2) hydroxychloroquine / azithromycin combined therapy can abolish the onset of these complications late. Furthermore, the results may point to the need for more rigorous monitoring of cardiologists and pulmonologists of these patients, due to the risk of hemodynamic complications, arrhythmogenic and respiratory.

详细描述

The aim of this study is to investigate the predictive role of cardiac biomarkers and significant pulmonary complications for late infection complications COVID-19 coronavirus on the heart and lung in patients treated with hydroxychloroquine / combination therapy azithromycin.

COVID-19 positive test patients will be divided into two groups according to therapeutic conduct. So, with a case-control distribution respecting age and sex, the two patient groups will be defined as "arm" with therapy (study population) and "Arm" without therapy (population control). This study is prospective and consists of three times:

  1. T0- Moment of inclusion of the patient in the study, which coincides with the collection of clinical data and laboratory tests.

(2) T3- In the 3rd month after inclusion in the study, the patient will make a medical visit where data new laboratory tests will be acquired.

(3) T12- In the 12th month after inclusion in the study, the patient will make another medical visit where data clinical data will be obtained. Laboratory tests, which were altered during visit T3 will be repeated.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • positive test for covid19
  • high ultrasensitive troponin
  • pulmonary damage > 25%
  • no cardiac or lung known disease
  • Consent inform signed

排除标准

  • intensive care and mechanical ventilation needs
  • chronic inflammatory disease
  • active neoplasm
  • use of immunosuppressant
  • renal failure
  • pregnant woman

结局指标

主要结局

Fibrosis

时间窗: 12 months

presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry

Ergospirometers

时间窗: 12 monthes

Decreased functional capacity on ergospirometers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Vicente Serrano Jr

Professor; doctoral supervisor

University of Sao Paulo General Hospital

研究点 (1)

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