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Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System (PostCOVID19)

2020年4月15日 更新者:Carlos Vicente Serrano Jr、University of Sao Paulo General Hospital

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

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.

研究概览

详细说明

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.

COVID-19 coronavirus patients undergoing therapy combined hydroxychloroquine / azithromycin will be compared to patients not undergoing this therapy. The comparison will be performed by analyzing the relationships between (1) troponin levels ultrasensitive cardiac data collected at the beginning of the infection and data of cardiac magnetic resonances in the 3rd and 12th month of collection troponins and (2) acute tomographic findings and the results the ergospirometers tests performed in those same periods.

In our understanding of COVID-19, its diagnosis, prevention and treatment are evolving quickly. As the disease spreads and new evidence emerges, it would be prudent to identify risk factors for the development of late cardiorespiratory complications in patients survivors of serious COVID-19 infections.

This prospective study of patients with COVID-19, involving a systematic record of clinical-laboratory variables and chronic cardiorespiratory complications, will be beneficial for the development of a risk model for these complications and to identify and / or predict the response to various treatment modalities.

研究类型

观察性的

注册 (预期的)

130

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • SP
      • São Paulo、SP、巴西
        • Instituto do Coração - Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

positive test for covid19

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Arm treatment (HCQ + Azithro)
Participants that used HCQ + Azithro in their treatment for COVID19
Organize care follow-up for patients who have had COVID-19 coronavirus infection for scientific purposes. Thus, it is expected to obtain relevant data on cardiac sequelae and pulmonary. These data are important for understanding the long-term prognosis of patients surviving this infection.
Arm control (without HCQ + Azithro)
Participants that did not used HCQ + Azithro in their treatment for COVID19
Organize care follow-up for patients who have had COVID-19 coronavirus infection for scientific purposes. Thus, it is expected to obtain relevant data on cardiac sequelae and pulmonary. These data are important for understanding the long-term prognosis of patients surviving this infection.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Fibrosis
大体时间:12 months
presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry
12 months
Ergospirometers
大体时间:12 monthes
Decreased functional capacity on ergospirometers
12 monthes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2020年6月1日

初级完成 (预期的)

2021年9月30日

研究完成 (预期的)

2021年9月30日

研究注册日期

首次提交

2020年4月15日

首先提交符合 QC 标准的

2020年4月15日

首次发布 (实际的)

2020年4月20日

研究记录更新

最后更新发布 (实际的)

2020年4月20日

上次提交的符合 QC 标准的更新

2020年4月15日

最后验证

2020年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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