NoRCoRP Assessment Clinic

Covid19 Clinical Trial

— NoRCoRP  

Official title:

The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04710836
• Other study ID #: 20RM056
• Status: Recruiting
• Start date: December 3, 2020
• Est. completion date: August 31, 2032

Study information

• Verified date: February 2021
• Source: Nottingham University Hospitals NHS Trust
• Contact: Charlotte Bolton
• Phone: 01159 691169
• Email: charlotte.bolton[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 31, 2032
• Est. primary completion date: August 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
United Kingdom	Nottingham City Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with symptoms at presentation to the research clinic	Patient reported symptoms	September 2020 - August 2024
Primary	Short Physical Performance Battery	Assessment of functional capacity	September 2020 - August 2024
Primary	Quadricep muscle strength	Assessment of functional capacity using a handheld dynamometer	September 2020 - August 2024
Primary	Chalder's Fatigue Score	Assessment of fatigue using the Chalder 11-item fatigue questionnaire	September 2020 - August 2024
Primary	Number of participants with rehabilitation needs at presentation to clinic	Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)	September 2020 - August 2024
Primary	EQ-5D-5L	Assessment of generic health status using the EQ-5D-5L questionnaire	September 2020 - August 2024
Primary	Montreal Cognitive Assessment	Assessment of cognitive state using the MoCA questionnaire	September 2020 - August 2024
Secondary	Anxiety and Depression	Derived by completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire	September 2020 - August 2024
Secondary	Pittsburgh Sleep Quality Index	Assessment of sleep quality using the PSQI questionnaire	September 2020 - August 2024
Secondary	Healthcare service needs following COVID-19 diagnosis	Monitoring of NHS records for incidence of re-presentation to primary or secondary care related to COVID-19 complications and survival.	September 2020 - August 2032
Secondary	Biological markers of recovery from COVID-19	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.	September 2020 - August 2032
Secondary	Fried Frailty Index	Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains.	September 2020 - August 2024
Secondary	Body composition	Body composition derived from bioelectrical impedance analysis to determine: body mass index, fat free mass index, fat free mass (kg), fat mass (kg).	September 2020 - August 2024