NoRCoRP Assessment Clinic (NoRCoRP)

The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults who have previous had a diagnosis of COVID-19 and have been referred into a post-COVID-19 respiratory outpatients clinic from primary care due to ongoing complications related to the COVID-19 diagnosis.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with symptoms at presentation to the research clinic
Time Frame: September 2020 - August 2024
Patient reported symptoms
September 2020 - August 2024
Short Physical Performance Battery
Time Frame: September 2020 - August 2024
Assessment of functional capacity
September 2020 - August 2024
Quadricep muscle strength
Time Frame: September 2020 - August 2024
Assessment of functional capacity using a handheld dynamometer
September 2020 - August 2024
Chalder's Fatigue Score
Time Frame: September 2020 - August 2024
Assessment of fatigue using the Chalder 11-item fatigue questionnaire
September 2020 - August 2024
Number of participants with rehabilitation needs at presentation to clinic
Time Frame: September 2020 - August 2024
Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)
September 2020 - August 2024
EQ-5D-5L
Time Frame: September 2020 - August 2024
Assessment of generic health status using the EQ-5D-5L questionnaire
September 2020 - August 2024
Montreal Cognitive Assessment
Time Frame: September 2020 - August 2024
Assessment of cognitive state using the MoCA questionnaire
September 2020 - August 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and Depression
Time Frame: September 2020 - August 2024
Derived by completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire
September 2020 - August 2024
Pittsburgh Sleep Quality Index
Time Frame: September 2020 - August 2024
Assessment of sleep quality using the PSQI questionnaire
September 2020 - August 2024
Healthcare service needs following COVID-19 diagnosis
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.
September 2020 - August 2032
Biological markers of recovery from COVID-19
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.
September 2020 - August 2032
Fried Frailty Index
Time Frame: September 2020 - August 2024
Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains.
September 2020 - August 2024
Body composition
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).
September 2020 - August 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charlotte Bolton, University of Nottingham & Nottingham University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2020

Primary Completion (Actual)

August 8, 2024

Study Completion (Actual)

August 8, 2024

Study Registration Dates

First Submitted

December 10, 2020

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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