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临床试验/NCT06022198
NCT06022198已完成不适用

Study of Bronchoalveolar Lavage in Patients Recovered From COVID-19 Pneumonia

Mohamed Abd Elmoniem Mohamed2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
evaluate BAL in post-acute COVID-19 patients

研究概览

简要总结

Coronaviruses such as SARS-CoV2, MERS-CoV, and SARS-CoV can cause significant morbidity and mortality in infected persons. Lung is the most common site of infection for these viruses, which may manifest as acute respiratory distress syndrome and mortality. Pulmonary involvement is also responsible for the high viral transmission The aim of this study is to evaluate BAL in post-acute COVID-19 patients for:Cytological and cellular patterns. Microbial analysis for possibility of presence of bacterial, mycobacerial or fungal co-infection.PCR for corona virus

详细描述

On December 31, 2019, a cluster of cases of pneumonia in people who were later linked to Wuhan Seafood Market in Wuhan, Hubei, China, were reported. Just a week later, Chinese health authorities confirmed that those cases were caused by a novel coronavirus, later named as SARS-CoV2 .

Till date, six coronavirus species are known to cause human diseases. Four of the already-known coronavirus species, i.e., 229E, OC43, NL63, and HKU1, are commonly circulating viruses in human population and cause mild common cold-like symptoms.

Two of the already-known strains of coronavirus, severe acute respiratory syndrome-coronavirus (SARS-CoV) and Middle East respiratory syndrome-CoV (MERS-CoV) are zoonotic in origin and cause serious illnesses which can be fatal.

Coronaviruses such as SARS-CoV2, MERS-CoV, and SARS-CoV can cause significant morbidity and mortality in infected persons. Lung is the most common site of infection for these viruses, which may manifest as acute respiratory distress syndrome and mortality. Pulmonary involvement is also responsible for the high viral transmission.

BAL, bronchial wash, and protected specimen brush are bronchoscopic procedures used to provide microbiological samples from lower respiratory airways. However, because of the risk of viral transmission, bronchoscopy is not routinely indicated for the diagnosis of COVID-19.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Patients with persistent pulmonary infiltrate one month after discharge from isolation building at Mansoura university hospitals, previously tested positive for SARS-CoV-2 infection by real-time PCR on nasopharyngeal swab during admission, discharged and discontinued transmission based precautions according to CDC guidance:
  • Symptom-Based Strategy for Discontinuing Transmission-Based Precautions (CDC, 2020)
  • Patients with mild to moderate illness who are not severely immunocompromised:
  • At least 10 days have passed since symptoms first appeared and
  • At least 24 hours have passed since last fever without the use of fever-reducing medications and
  • Symptoms (e.g., cough, shortness of breath) have improved
  • Patients with severe to critical illness or who are severely immunocompromised1:
  • At least 10 days and up to 20 days have passed since symptoms first appeared and
  • At least 24 hours have passed since last fever without the use of fever-reducing medications and
  • Symptoms (e.g., cough, shortness of breath) have improved
  • Consider consultation with infection control experts

排除标准

  • Age: patients less than 18 years old.
  • Patient refuse to undergo bronchoscopy.
  • Patients unfit for bronchoscopy (hemodynamic instability, recent myocardial infarction, severe hypoxia, uncooperative patient, severe bleeding disorder).
  • Patients known to have chronic airway pulmonary diseases or interstitial lung diseases

结局指标

主要结局

evaluate BAL in post-acute COVID-19 patients

时间窗: Baseline

Understanding the pathophysiological mechanisms of COVID-19 and nature of the immunological defense in lungs in response to viral infection by SARS-CoV2 is essential in order to initiate timely and targeted anti-inflammatory, anticoagulative, or even antifibrotic therapy

次要结局

未报告次要终点

研究者

发起方
Mohamed Abd Elmoniem Mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Abd Elmoniem Mohamed

Assistant lecturer

Mansoura University Hospital

研究点 (2)

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