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临床试验/NCT04473352
NCT04473352Unknown不适用

Diagnostic Accuracy of COVID-19 Detection Tests in Different Body Fluids of Infected Men and Concordance With Viral Cultures

Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara0 个研究点目标入组 80 人开始时间: 2020年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
Accuracy of Covid19 Detection

研究概览

简要总结

A clinical and experimental study will be carried out in which the clinician will investigate the PCR of the virus early in different body fluids (blood, semen, urine, saliva) and monitor its experimental clearance and evaluate in vitro diagnostic tests and inhibitory factors of viral proliferation.

详细描述

The World Health Organization (WHO) declared Coronavirus 2019 (COVID-19) as a pandemic on March 11, 2020. Due to the rapid spread of the severe acute respiratory syndrome coronavirus 2 virus (SARS-CoV-2), we are currently facing an unprecedented global situation. One of the main pillars in the control of an epidemic is the performance of large-scale tests providing a quick and accurate diagnosis so that the authorities can take timely action. Therefore, tests for COVID-19 should be prompt, widely available, and implemented outside the hospital environment, to avoid overloading the health system and decreasing the risks of hospital transmission to other patients and health professionals. Although universal testing is a cornerstone for reducing the burden of COVID-19, the accuracy of the commercially available tests for COVID-19 in Brazil remains uncertain. In addition, the natural history of the disease in the different organs and tissues is not unquestionably known, nor because the virus develops better in some tissues and not others. There are still many unanswered questions regarding COVID-19. allow more accurate knowledge of the natural history of the disease in the timeline taking into account the acute and long-term phases. Several families of viruses can affect the male genitourinary system, as is the case of the Zika (ZKV) and Ebola viruses. There are reports that in young patients infected with ZKV, the virus persists in semen for up to 6 months after the symptomatic condition. The other SARS-CoV-1 itself was detected in human testicles associated with an inflammatory process (orchiepididymitis), suggesting the possibility that these viruses could also be detected in the semen. As SARS-CoV-1 was able to overcome the hemato-gestural barrier and induce severe testicular damage in the previous outbreak, it is possible that men infected with COVID-19 may also have testicular damage. Another question that remains unanswered is whether the coronavirus can remain in the body of people considered recovered from Covid-19 for an indefinite period. It is also unknown whether there are molecules in the body fluids capable of inhibiting viral growth. The expected benefits are related to a better understanding of COVID's natural history19 and which body fluids can contribute to understanding the pathophysiology of the disease. It will be possible to identify the best time and the test with the best accuracy to diagnose the disease. It is our intention to identify substances in body fluids with an antiviral effect

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Subjects over the age of 18 years
  • Agreement with the IC

排除标准

  • History of previous prostate surgery or vasectomy
  • Inability to assess participation in the study

结局指标

主要结局

Accuracy of Covid19 Detection

时间窗: September 2021

Numerical variables will be described by measurements of central tendency (mean or median) and the respective dispersion measurements. Categorical variables will be described by their absolute values, percentages, or proportions. To compare the differences of continuous variables, we will use the Student t-test or the Mann-Whitney test. For comparison of categorical data, we will use the chi-square test. Univariable and multivariable analyses will be performed to identify predictors of COVID-19 detection.

次要结局

未报告次要终点

研究者

发起方
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ricardo Reges Maia de Oliveira

PhD

Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

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