Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System (PostCOVID19)
Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System: Effect of Hydroxychloroquine / Azithromycin Combined Therapy
研究概览
地位
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
注册 (预期的)
联系人和位置
学习地点
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SP
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São Paulo、SP、巴西
- Instituto do Coração - Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
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 |
|---|---|
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Arm treatment (HCQ + Azithro)
Participants that used HCQ + Azithro in their treatment for COVID19
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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.
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Arm control (without HCQ + Azithro)
Participants that did not used HCQ + Azithro in their treatment for COVID19
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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.
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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 |
|---|---|---|
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Fibrosis
大体时间:12 months
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presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry
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12 months
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Ergospirometers
大体时间:12 monthes
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Decreased functional capacity on ergospirometers
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12 monthes
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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