Major Determinants of COVID-19 Associated Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Serology
研究概览
简要总结
Molecular testing (e.g PCR) of respiratory tract samples is the recommended method for the identification and laboratory confirmation of COVID-19 cases.
Recent evidence reported that the diagnostic accuracy of many of the available RT-PCR tests for detecting SARS-CoV2 may be lower than optimal.
Of course, the economical and clinical implications of diagnostic errors are of foremost significance and in case of infectious outbreaks, namely pandemics, the repercussions are amplified. False positives and false-negative results may jeopardize the health of a single patient and may affect the efficacy of containment of the outbreak and of public health policies.
In particular, false-negative results contribute to the ongoing of the infection causing further spread of the virus within the community, masking also other potentially infected people.
详细描述
As demonstrated by a study conducted by Ai et al., including 1014 suspect COVID-19 cases who underwent multiple RT-PCR testing and chest-CT, overall 88% of patients had positive CT scans while RT-PCR positivity was found only in 59% of all cases. Also, as reported by Yang et al, the total positive rate of RT-PCR for throat swab samples was reported to be about 30% to 60% at initial presentation. Thus, a negative result does not exclude the possibility of infection and should not be used as the only criterion for treatment of patient and management decisions.
Reasons for false negative RT-PCR may include the lack of identification or inadequate procedures for specimen collection, handling and storage, as well as active viral recombination or testing carried out of the diagnostic window.
From preliminary studies has emerged that patients may show very early but significant CT changes even before RT-PCR studies. Hence, the necessity for developing a combined approach for the diagnosis of these particular patients who present with negative RT-PCR test results.
The investigators hypotheses is that several patients who presented with pneumonia confirmed at CT scan during the Coronavirus outbreak, and who tested negative for SARS-CoV2 at RT-PCR could probably be affected by the disease and need to be carefully observed.
Primary end-point The primary end-point of our prospective, observational study is to assess if inpatients who presented with pneumonia but had a negative test for Covid-19 are positive at the serology for SARS-CoV-2.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of pneumonia; Covid-19 test negative; hospitalized subjects; both sexes; given informed consent
排除标准
- •age lower than 18 years; pregnancy; breast-feeding
结局指标
主要结局
Serology
时间窗: 3 weeks
assess if inpatients who presented with pneumonia but had a negative test for Covid-19 are positive at the serology for SARS-CoV-2.
次要结局
- Efficacy of CT scan and Serology(3 weeks)
- Efficacy of different pharmaceutical treatments(3 weeks)
研究者
Geltrude Mingrone
Associate Professor of Internal Medicine
Catholic University of the Sacred Heart