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临床试验/NCT04813575
NCT04813575Unknown不适用

COVID 19 A Prospective Case Control Pathophysiological Study of Long Term Implications

King Faisal Specialist Hospital & Research Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Post COVID 19 infection development of respiratory failure

研究概览

简要总结

Coronavirus disease 2019 (COVID 19) is primarily a respiratory viral infection. At the time of writing this protocol, more than 25 million people have been affected globally. Of these, more than 850000 have died directly due to the disease. In the Kingdom of Saudi Arabia, there are as of now over 30000 cases and deaths from COVID 19. This has been declared as a Pandemic by WHO and has brought normal life to a standstill. There are many uncertainties regarding the pathophysiology and clinical course of this disease. It is estimated that 80 percent of those infected will not need special care. However, 1 in 5 (20%) patients will require hospitalization. Of these, typically, 5 percent will be critically ill and ventilated. Of those ventilated, 20 to 60 percent will die. However, this can vary from country to country due to various reasons. For example, in one study, 71.6% were hospitalized in the Kingdom of Saudi Arabia, and 4.6% were admitted to intensive care.

The rest of those who are hospitalized (95%), are at risk of having long term sequelae. From the SARS CoV infection data, 50 per cent had changes consistent with inflammatory lung disease at 4 weeks, and at 15 years, 4.6% (SD 6.4%) had pulmonary fibrosis. Middle East Respiratory Syndrome (MERS) had typical lower lobe fibrotic changes in more than one-third of the patients. SARS CoV2 virus shares 79.5% sequence identity with SARS CoV and 50% with MERS CoV. The SARS CoV2 may also have similarities in the inflammatory response; emerging data shows that COVID 19 patients also have new interstitial lung disease changes and thromboembolic disease. These patients may have long term physiological disability such as exertional hypoxia, breathlessness, reduction in static and dynamic lung volumes and diffusion factors.

There is currently no data available to predict who is at risk of developing long term chronic thromboembolic disease and interstitial lung disease. More importantly, there are no data available on the pathological changes of inflammatory lung disease. Pathologically classifying the disease may have a significant impact on the choice of the treatment for these patients who otherwise have the potential to be disabled lifelong. With appropriate phenotyping, appropriate risk reduction strategies and targeted therapies can be considered. Furthermore, studying biomarkers that could potentially identify those at-risk patients from very early on can provide an opportunity to start on the treatment very early on in the natural course of the disease history.

详细描述

COVID 19. A prospective case-control pathophysiological study of long term implications.

The rationale of the study To identify the phenotype of patients who would have long term complications from COVID 19 The investigators hypothesize that

  1. Cytokine and inflammatory biomarkers and histopathology will allow phenotyping of patients with COVID 19 disease
  2. That clinical, histopathological and radiological correlation may provide further information into the different phenotypes of COVID 19 patients.

Aim and Objectives of the study Primary objective: To phenotype COVID 19 patients based on biomarkers

Secondary objectives:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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
否

入选标准

  • •Patients presenting with COVID symptoms to hospitals.
  • •Patients >18 years old

排除标准

  • •Patients without capacity to consent
  • •Pulmonary oedema secondary to decompensated cardiac, renal or liver disease at the time of admission
  • •Interstitial lung disease at the time of presentation
  • •Known lymphangitis carcinomatosis
  • •Morbidly obese patients with BMI more than 40
  • •Patients with known pulmonary hypertension or if the clinician feels there are other reasons for pulmonary hypertension than cardiomyopathy secondary to COVID
  • •Pregnant women

研究组 & 干预措施

Intervention arm

Experimental

Experimental arm patients will have cryobiopsies for histological analysis of the ongoing pathology

干预措施: Cryo lung biopsies (Other)

control group

No Intervention

This arm will be control group and will be observed prospectively

结局指标

主要结局

Post COVID 19 infection development of respiratory failure

时间窗: 12- 18 months

incidence of respiratory failure post COVID 19 infection

次要结局

  • Pathology of long term lung complications in COVID 19(12 - 18 months)
  • Risk factors for thromboembolic disease(12-18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Alhajji

Doctor

King Faisal Specialist Hospital & Research Center

研究点 (1)

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