NCT04710836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2024

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

December 10, 2020

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • Number of participants with symptoms at presentation to the research clinic

    Patient reported symptoms

    September 2020 - August 2024

  • Short Physical Performance Battery

    Assessment of functional capacity

    September 2020 - August 2024

  • Quadricep muscle strength

    Assessment of functional capacity using a handheld dynamometer

    September 2020 - August 2024

  • Chalder's Fatigue Score

    Assessment of fatigue using the Chalder 11-item fatigue questionnaire

    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)

    September 2020 - August 2024

  • EQ-5D-5L

    Assessment of generic health status using the EQ-5D-5L questionnaire

    September 2020 - August 2024

  • Montreal Cognitive Assessment

    Assessment of cognitive state using the MoCA questionnaire

    September 2020 - August 2024

Secondary Outcomes (6)

  • Anxiety and Depression

    September 2020 - August 2024

  • Pittsburgh Sleep Quality Index

    September 2020 - August 2024

  • Healthcare service needs following COVID-19 diagnosis

    September 2020 - August 2032

  • Biological markers of recovery from COVID-19

    September 2020 - August 2032

  • Fried Frailty Index

    September 2020 - August 2024

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be stored for later analysis of DNA. This will only be stored with the specific consent of the patient as outlined in the consent form.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Charlotte Bolton

    University of Nottingham & Nottingham University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2020

First Posted

January 15, 2021

Study Start

December 3, 2020

Primary Completion

August 8, 2024

Study Completion

August 8, 2024

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations