Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
NCT Number: NCT04710836
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.
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Notify Me18 year and older
All sexes
Observational
Nottingham, NG5 1PB, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: September 2020 - August 2024
Patient reported symptoms
Time frame: September 2020 - August 2024
Assessment of functional capacity
Time frame: September 2020 - August 2024
Assessment of functional capacity using a handheld dynamometer
Time frame: September 2020 - August 2024
Assessment of fatigue using the Chalder 11-item fatigue questionnaire
Time frame: September 2020 - August 2024
Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)
Time frame: September 2020 - August 2024
Assessment of generic health status using the EQ-5D-5L questionnaire
Time frame: September 2020 - August 2024
Assessment of cognitive state using the MoCA questionnaire
Time frame: September 2020 - August 2024
Derived by completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire
Time frame: September 2020 - August 2024
Assessment of sleep quality using the PSQI questionnaire
Time frame: September 2020 - August 2032
Monitoring of NHS records for incidence of re-presentation to primary or secondary care related to COVID-19 complications and survival.
Time frame: September 2020 - August 2032
Assessment of blood taken for clinical purposes (where available) including renal function, liver function, full blood count, HbA1C, Brain natriuretic peptide, vitamin D, thyroid function, C-reactive protein (CRP), Creatine kinase for markers of COVID-19 recovery. Batched inflammatory and metabolic markers as well as whole blood DNA will also be assessed from stored samples.
Time frame: September 2020 - August 2024
Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains.
Time frame: September 2020 - August 2024
Body composition derived from bioelectrical impedance analysis to determine: body mass index, fat free mass index, fat free mass (kg), fat mass (kg).
Nottingham University Hospitals NHS Trust
Other
The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic
Acronym: NoRCoRP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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