Covid19NoRCoRPNCT04710836
NoRCoRP Assessment Clinic
An observational study of Covid19, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 254 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Dec 2020to 8 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with symptoms at presentation to the research clinic
Patient reported symptoms
Measured: September 2020 - August 2024
Short Physical Performance Battery
Assessment of functional capacity
Measured: September 2020 - August 2024
Quadricep muscle strength
Assessment of functional capacity using a handheld dynamometer
Measured: September 2020 - August 2024
Chalder's Fatigue Score
Assessment of fatigue using the Chalder 11-item fatigue questionnaire
Measured: September 2020 - August 2024
Number of participants with rehabilitation needs at presentation to clinic
Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)
Measured: September 2020 - August 2024
EQ-5D-5L
Assessment of generic health status using the EQ-5D-5L questionnaire
Measured: September 2020 - August 2024
Montreal Cognitive Assessment
Assessment of cognitive state using the MoCA questionnaire
Measured: September 2020 - August 2024
Secondary outcomes (6)
Anxiety and Depression
Derived by completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire
Measured: September 2020 - August 2024
Pittsburgh Sleep Quality Index
Assessment of sleep quality using the PSQI questionnaire
Measured: September 2020 - August 2024
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.
Measured: September 2020 - August 2032
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.
Measured: September 2020 - August 2032
Fried Frailty Index
Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains.
Measured: September 2020 - August 2024
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).
Measured: September 2020 - August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start3 Dec 2020
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Bolton, Principal investigator, University of Nottingham & Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710836
- Sponsor's protocol ID
- 20RM056
- Acronym
- NoRCoRP
- Status last verified
- Jun 2025
- First submitted
- 10 Dec 2020
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic
- ClinicalTrials.gov ID
- NCT04710836
- Acronym / sponsor ID
- NoRCoRP / 20RM056
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with symptoms at presentation to the research clinic
Time frame: September 2020 - August 2024
Patient reported symptoms
Short Physical Performance Battery
Time frame: September 2020 - August 2024
Assessment of functional capacity
Quadricep muscle strength
Time frame: September 2020 - August 2024
Assessment of functional capacity using a handheld dynamometer
Chalder's Fatigue Score
Time frame: September 2020 - August 2024
Assessment of fatigue using the Chalder 11-item fatigue questionnaire
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)
EQ-5D-5L
Time frame: September 2020 - August 2024
Assessment of generic health status using the EQ-5D-5L questionnaire
Montreal Cognitive Assessment
Time frame: September 2020 - August 2024
Assessment of cognitive state using the MoCA questionnaire
6 secondary outcomes
Anxiety and Depression
Time frame: September 2020 - August 2024
Pittsburgh Sleep Quality Index
Time frame: September 2020 - August 2024
Healthcare service needs following COVID-19 diagnosis
Time frame: September 2020 - August 2032
Biological markers of recovery from COVID-19
Time frame: September 2020 - August 2032
Fried Frailty Index
Time frame: September 2020 - August 2024
Body composition
Time frame: September 2020 - August 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Bolton principal investigator
University of Nottingham & Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with symptoms at presentation to the research clinic (time frame: September 2020 - August 2024). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.