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临床试验/NCT04710836
NCT04710836已完成不适用

The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic

Nottingham University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2020年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
254
试验地点
1
主要终点
Number of participants with symptoms at presentation to the research clinic

研究概览

简要总结

The main overarching aim of this study is to build a research clinic, as part of the NoRCoRP platform covering Nottingham and Nottinghamshire to facilitate learning and research in the whole population of patients who have had COVID-19.

详细描述

The severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2 / COVID-19) pandemic, has affected over 13 million people, and caused significant worldwide mortality and morbidity. Frequent long-term respiratory complications include persistent breathlessness and fatigue, with potential for ongoing organising pneumonia and new pulmonary fibrosis as well as thromboembolic disease. Additional features seen in at least some patients post hospital include impaired musculoskeletal function, impaired renal function, neurological impairment, cardiac dysfunction and significant psychiatric morbidity.

The majority of patients with COVID-19 were not admitted to hospital, and the longer-term consequences of infection with SARS-CoV-2 in this much larger patient group are unknown. Whilst many patients had relatively mild disease and made a good recovery, a significant number have been left with symptoms similar to those who were admitted to hospital.

In setting up a post COVID-19 respiratory review clinic, we expect to generate new findings, support studies that have already been submitted for funding, to provide a focus for further grant funding, and to provide an infrastructure to support new clinical trials. We also expect the insights gained from research using this platform to be of value for service planning in the region and beyond. We will prioritise patients who were not admitted to hospital but who have been left with significant morbidity by establishing this new General Practitioner (GP) referral research clinic.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Adults (≥18 years) referred into the post COVID-19 respiratory outpatient clinic from primary care, following a swab, imaging or strong clinical diagnosis of COVID-19
  • Adults discharged from hospital with a clinical diagnosis of COVID-19 (who are not included in the PHOSP-COVID study)

排除标准

  • Children (<18 years) referred into the post COVID-19 respiratory outpatient clinic. This clinic is only open to adults and referrals for children will not be accepted
  • Adults discharged from hospital with a clinical diagnosis of COVID-19 and have been included in the PHOSP-COVID study
  • Patients unable to provide informed consent by themselves

结局指标

主要结局

Number of participants with symptoms at presentation to the research clinic

时间窗: September 2020 - August 2024

Patient reported symptoms

Quadricep muscle strength

时间窗: September 2020 - August 2024

Assessment of functional capacity using a handheld dynamometer

Number of participants with rehabilitation needs at presentation to clinic

时间窗: September 2020 - August 2024

Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)

EQ-5D-5L

时间窗: September 2020 - August 2024

Assessment of generic health status using the EQ-5D-5L questionnaire

Montreal Cognitive Assessment

时间窗: September 2020 - August 2024

Assessment of cognitive state using the MoCA questionnaire

Chalder's Fatigue Score

时间窗: September 2020 - August 2024

Assessment of fatigue using the Chalder 11-item fatigue questionnaire

Short Physical Performance Battery

时间窗: September 2020 - August 2024

Assessment of functional capacity

次要结局

  • Healthcare service needs following COVID-19 diagnosis(September 2020 - August 2032)
  • Fried Frailty Index(September 2020 - August 2024)
  • Biological markers of recovery from COVID-19(September 2020 - August 2032)
  • Body composition(September 2020 - August 2024)
  • Anxiety and Depression(September 2020 - August 2024)
  • Pittsburgh Sleep Quality Index(September 2020 - August 2024)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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