Clinical trial NCT04710836: NoRCoRP Assessment Clinic
Official title: The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with symptoms at presentation to the research clinic
timeFrame: September 2020 - August 2024
measure: Short Physical Performance Battery
timeFrame: September 2020 - August 2024
measure: Quadricep muscle strength
timeFrame: September 2020 - August 2024
measure: Chalder's Fatigue Score
timeFrame: September 2020 - August 2024
measure: Number of participants with rehabilitation needs at presentation to clinic
timeFrame: September 2020 - August 2024
measure: EQ-5D-5L
timeFrame: September 2020 - August 2024
measure: Montreal Cognitive Assessment
timeFrame: September 2020 - August 2024
Secondary outcomes:
measure: Anxiety and Depression
timeFrame: September 2020 - August 2024
measure: Pittsburgh Sleep Quality Index
timeFrame: September 2020 - August 2024
measure: Healthcare service needs following COVID-19 diagnosis
timeFrame: September 2020 - August 2032
measure: Biological markers of recovery from COVID-19
timeFrame: September 2020 - August 2032
measure: Fried Frailty Index
timeFrame: September 2020 - August 2024
measure: Body composition
timeFrame: September 2020 - August 2024
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
affiliation: University of Nottingham & Nottingham University Hospitals NHS Trust
name: Charlotte Bolton
role: PRINCIPAL_INVESTIGATOR
References: