- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04710836
NoRCoRP Assessment Clinic (NoRCoRP)
The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nottingham, United Kingdom, NG5 1PB
- Nottingham City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of participants with symptoms at presentation to the research clinic
Time Frame: September 2020 - August 2024
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Patient reported symptoms
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September 2020 - August 2024
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Short Physical Performance Battery
Time Frame: September 2020 - August 2024
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Assessment of functional capacity
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September 2020 - August 2024
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Quadricep muscle strength
Time Frame: September 2020 - August 2024
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Assessment of functional capacity using a handheld dynamometer
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September 2020 - August 2024
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Chalder's Fatigue Score
Time Frame: September 2020 - August 2024
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Assessment of fatigue using the Chalder 11-item fatigue questionnaire
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September 2020 - August 2024
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Number of participants with rehabilitation needs at presentation to clinic
Time Frame: September 2020 - August 2024
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Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)
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September 2020 - August 2024
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EQ-5D-5L
Time Frame: September 2020 - August 2024
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Assessment of generic health status using the EQ-5D-5L questionnaire
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September 2020 - August 2024
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Montreal Cognitive Assessment
Time Frame: September 2020 - August 2024
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Assessment of cognitive state using the MoCA questionnaire
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September 2020 - August 2024
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anxiety and Depression
Time Frame: September 2020 - August 2024
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Derived by completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire
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September 2020 - August 2024
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Pittsburgh Sleep Quality Index
Time Frame: September 2020 - August 2024
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Assessment of sleep quality using the PSQI questionnaire
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September 2020 - August 2024
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Healthcare service needs following COVID-19 diagnosis
Time Frame: September 2020 - August 2032
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Monitoring of NHS records for incidence of re-presentation to primary or secondary care related to COVID-19 complications and survival.
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September 2020 - August 2032
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Biological markers of recovery from COVID-19
Time Frame: September 2020 - August 2032
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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.
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September 2020 - August 2032
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Fried Frailty Index
Time Frame: September 2020 - August 2024
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Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains.
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September 2020 - August 2024
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Body composition
Time Frame: September 2020 - August 2024
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Body composition derived from bioelectrical impedance analysis to determine: body mass index, fat free mass index, fat free mass (kg), fat mass (kg).
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September 2020 - August 2024
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Collaborators and Investigators
Investigators
- Principal Investigator: Charlotte Bolton, University of Nottingham & Nottingham University Hospitals NHS Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20RM056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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