COVID-19LOCOMOTIONNCT05057260
LOng COvid Multidisciplinary Consortium: Optimising Treatments and servIces Across the NHS (LOCOMOTION)
An observational study of COVID-19, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Background: Long Covid (LC) affects over one million people in the UK, it has various symptoms and impacts daily life. Although there are 83 LC clinics in England, most people have not had access to them, and waiting times to be seen are long. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- No drug invervention
- How many people
- 7,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jan 2022to 31 Dec 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: Patients referred into one of the ten Long Covid services by their General Practitioner (GP), or other clinicians (Positive Antigen or Antibody test is not required.)
Who may be able to join
- Age 18 and over, receiving care for Long Covid symptoms at one of the participating LC sites.
- Willing and able to consent for their data to be used for research and/or service evaluation purposes. Consent will be gathered via patient information sheet and formal recording of consent (on the phone application).
Who cannot join
- Inability to independently complete electronic or paper-based outcome measures, questionnaires or other research-based paperwork.
- Unable to give Informed Consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Leeds
Leeds, Yorkshire, LS1 3EX
Manoj Sivan, MD, m.sivan@leeds.ac.uk
About this study
Background: Long Covid (LC) affects over one million people in the UK, it has various symptoms and impacts daily life. Although there are 83 LC clinics in England, most people have not had access to them, and waiting times to be seen are long. We realise the urgency for LC patients to access prompt and appropriate care in clinics and doctors' surgeries, as well as manage their symptoms effectively at home.
Aim:Our research aims to produce a 'gold standard' for care by analysing what is happening to patients now, creating new systems of care and evaluating them to establish best practice.
Read more
Outline Of Research: This research has been developed with LC patients and will continue to include patients working as equal partners. Key priorities of LC patients are: correct clinical assessment; advice and treatment; and help with returning to work and other roles. This research is also based on the experience of a wide range of NHS professionals already treating people in ten LC clinics across the UK, and led by academics (universities) with links to other LC funded studies.
The research will take place in three settings: LC clinics; at home (including self-monitoring on a mobile device using a set of questions on symptoms built into an app); and in doctors' surgeries. We will track where patients are being referred or not referred, and learn from the experience of clinics by interviewing patients and recording outcomes. Throughout, specialists in 'Healthcare Inequality' will reach people who are not accessing clinics. We will put in place new processes in clinics and doctors' surgeries, monitored throughout to make sure they are the correct standard, accessible for patients and staff, and cost-effective.
Outcomes: Comparing findings across our partnership of ten LC Clinics we will learn more about treatment, providing real-time education to other healthcare staff and patients, and establishing a 'gold standard' that can be shared within England and the rest of the UK.
Read the detailed description
Background: Long COVID (LC) or Post-COVID syndrome affects up to one million people in the UK and is a syndrome of persistent and fluctuating symptoms, with underlying organ dysfunction and multimorbidity. England has 83 dedicated multidisciplinary LC clinics (with no funding yet in Scotland, Wales or Northern Ireland), but these are unable to meet the growing demand and many patients are currently not getting timely care. There is an urgent need to develop a UK-wide efficient integrated LC service.
Aim: We will optimise LC management across three settings of care - LC specialist clinics (Work stream (WS)1); Homes/self-management (WS2) and Primary care (WS3).
Methods: WS1: The management options for multisystem medical problems will be standardised to derive best practice guidance using a Quality Improvement collaborative involving embedded clinician researchers from 10 UK-wide LC clinics. Experience-based co-design with patients and healthcare professionals will inform training and resources for both. Ethnic and socioeconomic inequalities of care and vocational challenges of patients will be addressed using qualitative and mixed methods approaches.
WS2: A digital platform incorporating wearable technology will capture symptom fluctuations and individual condition triggers to enable biofeedback for self-management. Core outcomes measures including the first published LC patient-reported outcome measure (Yorkshire Rehabilitation Scale C19 YRS, developed by the co-CI) will be made available on the digital platform for monitoring and directing interventions remotely.
WS3: Existing primary care and LC clinic integrated data will assist in developing and evaluating new integrated cost-effective service models that will enable the best practice guidance developed in WS1 to be delivered at point of contact in primary care. We have links with previously funded NIHR LC projects to enable co-learning and maximising impact.
PPI/E: From understanding how COVID-19 has disproportionately affected different communities, we have created a seven-member core PPI Advisory Group (PAG) that is inclusive of different cultural, ethnic and socio-economic groups. They have attended our proposal research planning meetings and met separately to examine and develop the research aim/objectives/ questions, ensuring these are aligned with the key research priorities of patients with LC as well as representing different patient needs.
PAG members have lived experience of LC, and bring information and experience from participating in patient support groups including Long Covid Support (n=38K), doctors with LC and a LC Physio. PAG members have been involved in research design for previous NIHR bids, have acted as patient representatives on the NHS England LC Taskforce, and have led national audits on access to LC clinics. The PPI Lead is a founding member of the LC Employment Taskforce of Society of Occupational Medicine and a representative on the Access to WHO Covid Therapies Accelerator (ACT-A) committee. Some members meet weekly as members of Employment Steering Group of the LC Support Group including liaising with Unions.
In this study, the PAG will meet quarterly to review progress, ensure the research is answering the most relevant urgent issues in LC care and that the findings are translational and rapidly informing LC care. To ensure the different demographics of each of the ten LC Clinics are represented, two PPI members from each Clinic will be invited to join a Patient Advisory Network (PAN). Information will flow between the PAG and the PAN via the PPI Lead and Co-lead, ensuring that the voices of the PAN are represented within the PAG, and that they receive updates about research activity in the same way as PAG members. With support from the PPI Lead and Co-lead, PAN members will have an active role in gathering and sharing local intelligence about various aspects of the LC experience and LC Clinic access from LC patients representative of different groups e.g. via the voluntary sector and GP surgeries in different locations, including remote areas where there may be more elderly people with less access to LC clinics. The PPI Facilitator will provide the PAN members with PPI training, and provide them with the appropriate support needed to carry these activities out and contribute to the PAG.
- Conditions
- COVID-19
- Being tested
- No drug invervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drug inverventionOther
No clinical trial
| Study group | Role | What they receive |
|---|---|---|
| Long Covid cohort | Long Covid patients managed in the 10 participating sites Receives: Other: No drug invervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Quality of Life Five Dimensions
Quality of Life VAS score min 0 max 100
Measured: 2 years
COVID-19 Yorkshire Rehabilitation Scale
Symptom severity (min 0 max 100) and functional disability (min 0 max 50) and health state (min 0 max 10)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start18 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, University of Oxford, University of Exeter, King's College London, University of Manchester, University of Dundee, Leeds Comunity Healthcare NHS Trust, Oxford University Hospitals NHS Trust, Imperial College Healthcare NHS Trust, University Hospitals, Leicester, Birmingham Community Healthcare NHS, NHS Tayside, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospital of Wales
- Responsible party
- Principal investigator, Dr Manoj Sivan, University of Leeds
- Investigators
- Manoj Sivan, MD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057260
- Sponsor's protocol ID
- 303623
- Acronym
- LOCOMOTION
- Status last verified
- Oct 2022
- First submitted
- 23 Sep 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rayner C, Smith N, Milne R, Mir G, de Kock J, Bakerly ND; LOCOMOTION Consortium. 'What Do People With Long Covid Want From Healthcare Services?' A Qualitative Exploration From Lived Experience. Health Expect. 2026 Apr;29(2):e70607. doi: 10.1111/hex.70607.
PubMed 41736389Horton M, Smith AB, Milne R, Winch D, Rayner C, Halpin S, O'Connor R, Rocha Lawrence R, Greenwood DC, Bakerly ND, Evans R, Kwon J, Dawes H, Wood C, Williams P, Master H, Mansoubi M, De Kock JH, Mullard J, Ormerod M, Mir G, Petrou S, O'Connor DB, Sivan M; LOCOMOTION Consortium. Large-Scale Psychometric Assessment and Validation of the Modified COVID-19 Yorkshire Rehabilitation Scale Patient-Reported Outcome Measure for Long COVID or Post-COVID Syndrome. J Med Virol. 2026 Feb;98(2):e70816. doi: 10.1002/jmv.70816.
PubMed 41586458Lee C, Williams P, Abrahams A, Darbyshire J, Davies HE, De Kock J, Esmer U, Jones SA, Newey V, Scott J, Smith N, Winch D, Master H, Elkin S; LOCOMOTION Consortium. What Can We Learn Four Years On? A Multi-Centre Service Evaluation Exploring Symptoms, Functional Impact, Recovery and Care Pathways in Long Covid. Health Expect. 2025 Dec;28(6):e70435. doi: 10.1111/hex.70435.
PubMed 41199609Mullard J, Mir G, Herbert C, Evans S; LOCOMOTION Consortium. 'You're just a Guinea pig': Exploring the barriers and impacts of living with long COVID-19: A view from the undiagnosed. Sociol Health Illn. 2024 Nov;46(8):1602-1625. doi: 10.1111/1467-9566.13795. Epub 2024 Jun 8.
PubMed 38850204Greenhalgh T, Darbyshire JL, Lee C, Ladds E, Ceolta-Smith J. What is quality in long covid care? Lessons from a national quality improvement collaborative and multi-site ethnography. BMC Med. 2024 Apr 15;22(1):159. doi: 10.1186/s12916-024-03371-6.
PubMed 38616276Lee C, Greenwood DC, Master H, Balasundaram K, Williams P, Scott JT, Wood C, Cooper R, Darbyshire JL, Gonzalez AE, Davies HE, Osborne T, Corrado J, Iftekhar N, Rogers N, Delaney B, Greenhalgh T, Sivan M; LOCOMOTION Consortium. Prevalence of orthostatic intolerance in long covid clinic patients and healthy volunteers: A multicenter study. J Med Virol. 2024 Mar;96(3):e29486. doi: 10.1002/jmv.29486.
PubMed 38456315Mullard JCR, Kawalek J, Parkin A, Rayner C, Mir G, Sivan M, Greenhalgh T. Towards evidence-based and inclusive models of peer support for long covid: A hermeneutic systematic review. Soc Sci Med. 2023 Mar;320:115669. doi: 10.1016/j.socscimed.2023.115669. Epub 2023 Jan 14.
PubMed 36708608Sivan M, Greenhalgh T, Darbyshire JL, Mir G, O'Connor RJ, Dawes H, Greenwood D, O'Connor D, Horton M, Petrou S, de Lusignan S, Curcin V, Mayer E, Casson A, Milne R, Rayner C, Smith N, Parkin A, Preston N, Delaney B; LOCOMOTION consortium. LOng COvid Multidisciplinary consortium Optimising Treatments and servIces acrOss the NHS (LOCOMOTION): protocol for a mixed-methods study in the UK. BMJ Open. 2022 May 17;12(5):e063505. doi: 10.1136/bmjopen-2022-063505.
PubMed 35580970
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOng COvid Multidisciplinary Consortium: Optimising Treatments and servIces Across the NHS (LOCOMOTION)
- ClinicalTrials.gov ID
- NCT05057260
- Acronym / sponsor ID
- LOCOMOTION / 303623
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Imperial College London, University of Oxford, University of Exeter, King's College London, University of Manchester, University of Dundee, Leeds Comunity Healthcare NHS Trust, Oxford University Hospitals NHS Trust, Imperial College Healthcare NHS Trust, University Hospitals, Leicester, Birmingham Community Healthcare NHS, NHS Tayside, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospital of Wales
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Sep 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.
Background: Long Covid (LC) affects over one million people in the UK, it has various symptoms and impacts daily life. Although there are 83 LC clinics in England, most people have not had access to them, and waiting times to be seen are long. We realise the urgency for LC patients to access prompt and appropriate care in clinics and doctors' surgeries, as well as manage their symptoms effectively at home.
Aim:Our research aims to produce a 'gold standard' for care by analysing what is happening to patients now, creating new systems of care and evaluating them to establish best practice.
Outline Of Research: This research has been developed with LC patients and will continue to include patients working as equal partners. Key priorities of LC patients are: correct clinical assessment; advice and treatment; and help with returning to work and other roles. This research is also based on the experience of a wide range of NHS professionals already treating people in ten LC clinics across the UK, and led by academics (universities) with links to other LC funded studies.
The research will take place in three settings: LC clinics; at home (including self-monitoring on a mobile device using a set of questions on symptoms built into an app); and in doctors' surgeries. We will track where patients are being referred or not referred, and learn from the experience of clinics by interviewing patients and recording outcomes. Throughout, specialists in 'Healthcare Inequality' will reach people who are not accessing clinics. We will put in place new processes in clinics and doctors' surgeries, monitored throughout to make sure they are the correct standard, accessible for patients and staff, and cost-effective.
Outcomes: Comparing findings across our partnership of ten LC Clinics we will learn more about treatment, providing real-time education to other healthcare staff and patients, and establishing a 'gold standard' that can be shared within England and the rest of the UK.
Detailed description
Background: Long COVID (LC) or Post-COVID syndrome affects up to one million people in the UK and is a syndrome of persistent and fluctuating symptoms, with underlying organ dysfunction and multimorbidity. England has 83 dedicated multidisciplinary LC clinics (with no funding yet in Scotland, Wales or Northern Ireland), but these are unable to meet the growing demand and many patients are currently not getting timely care. There is an urgent need to develop a UK-wide efficient integrated LC service.
Aim: We will optimise LC management across three settings of care - LC specialist clinics (Work stream (WS)1); Homes/self-management (WS2) and Primary care (WS3).
Methods: WS1: The management options for multisystem medical problems will be standardised to derive best practice guidance using a Quality Improvement collaborative involving embedded clinician researchers from 10 UK-wide LC clinics. Experience-based co-design with patients and healthcare professionals will inform training and resources for both. Ethnic and socioeconomic inequalities of care and vocational challenges of patients will be addressed using qualitative and mixed methods approaches.
WS2: A digital platform incorporating wearable technology will capture symptom fluctuations and individual condition triggers to enable biofeedback for self-management. Core outcomes measures including the first published LC patient-reported outcome measure (Yorkshire Rehabilitation Scale C19 YRS, developed by the co-CI) will be made available on the digital platform for monitoring and directing interventions remotely.
WS3: Existing primary care and LC clinic integrated data will assist in developing and evaluating new integrated cost-effective service models that will enable the best practice guidance developed in WS1 to be delivered at point of contact in primary care. We have links with previously funded NIHR LC projects to enable co-learning and maximising impact.
PPI/E: From understanding how COVID-19 has disproportionately affected different communities, we have created a seven-member core PPI Advisory Group (PAG) that is inclusive of different cultural, ethnic and socio-economic groups. They have attended our proposal research planning meetings and met separately to examine and develop the research aim/objectives/ questions, ensuring these are aligned with the key research priorities of patients with LC as well as representing different patient needs.
PAG members have lived experience of LC, and bring information and experience from participating in patient support groups including Long Covid Support (n=38K), doctors with LC and a LC Physio. PAG members have been involved in research design for previous NIHR bids, have acted as patient representatives on the NHS England LC Taskforce, and have led national audits on access to LC clinics. The PPI Lead is a founding member of the LC Employment Taskforce of Society of Occupational Medicine and a representative on the Access to WHO Covid Therapies Accelerator (ACT-A) committee. Some members meet weekly as members of Employment Steering Group of the LC Support Group including liaising with Unions.
In this study, the PAG will meet quarterly to review progress, ensure the research is answering the most relevant urgent issues in LC care and that the findings are translational and rapidly informing LC care. To ensure the different demographics of each of the ten LC Clinics are represented, two PPI members from each Clinic will be invited to join a Patient Advisory Network (PAN). Information will flow between the PAG and the PAN via the PPI Lead and Co-lead, ensuring that the voices of the PAN are represented within the PAG, and that they receive updates about research activity in the same way as PAG members. With support from the PPI Lead and Co-lead, PAN members will have an active role in gathering and sharing local intelligence about various aspects of the LC experience and LC Clinic access from LC patients representative of different groups e.g. via the voluntary sector and GP surgeries in different locations, including remote areas where there may be more elderly people with less access to LC clinics. The PPI Facilitator will provide the PAN members with PPI training, and provide them with the appropriate support needed to carry these activities out and contribute to the PAG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long Covid cohort | – | Other: No drug inverventionLong Covid patients managed in the 10 participating sites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred into one of the ten Long Covid services by their General Practitioner (GP), or other clinicians (Positive Antigen or Antibody test is not required.)
Key inclusion criteria (2 listed)
- Age 18 and over, receiving care for Long Covid symptoms at one of the participating LC sites.
- Willing and able to consent for their data to be used for research and/or service evaluation purposes. Consent will be gathered via patient information sheet and formal recording of consent (on the phone application).
Key exclusion criteria (2 listed)
- Inability to independently complete electronic or paper-based outcome measures, questionnaires or other research-based paperwork.
- Unable to give Informed Consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No drug inverventionNo clinical trial | Other | Long Covid cohort |
Primary outcome
European Quality of Life Five Dimensions
Time frame: 2 years
Quality of Life VAS score min 0 max 100
COVID-19 Yorkshire Rehabilitation Scale
Time frame: 2 years
Symptom severity (min 0 max 100) and functional disability (min 0 max 50) and health state (min 0 max 10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 41736389Rayner C, Smith N, Milne R, Mir G, de Kock J, Bakerly ND; LOCOMOTION Consortium. 'What Do People With Long Covid Want From Healthcare Services?' A Qualitative Exploration From Lived Experience. Health Expect. 2026 Apr;29(2):e70607. doi: 10.1111/hex.70607.
- Derived from this study: PubMed 41586458Horton M, Smith AB, Milne R, Winch D, Rayner C, Halpin S, O'Connor R, Rocha Lawrence R, Greenwood DC, Bakerly ND, Evans R, Kwon J, Dawes H, Wood C, Williams P, Master H, Mansoubi M, De Kock JH, Mullard J, Ormerod M, Mir G, Petrou S, O'Connor DB, Sivan M; LOCOMOTION Consortium. Large-Scale Psychometric Assessment and Validation of the Modified COVID-19 Yorkshire Rehabilitation Scale Patient-Reported Outcome Measure for Long COVID or Post-COVID Syndrome. J Med Virol. 2026 Feb;98(2):e70816. doi: 10.1002/jmv.70816.
- Derived from this study: PubMed 41199609Lee C, Williams P, Abrahams A, Darbyshire J, Davies HE, De Kock J, Esmer U, Jones SA, Newey V, Scott J, Smith N, Winch D, Master H, Elkin S; LOCOMOTION Consortium. What Can We Learn Four Years On? A Multi-Centre Service Evaluation Exploring Symptoms, Functional Impact, Recovery and Care Pathways in Long Covid. Health Expect. 2025 Dec;28(6):e70435. doi: 10.1111/hex.70435.
- Derived from this study: PubMed 38850204Mullard J, Mir G, Herbert C, Evans S; LOCOMOTION Consortium. 'You're just a Guinea pig': Exploring the barriers and impacts of living with long COVID-19: A view from the undiagnosed. Sociol Health Illn. 2024 Nov;46(8):1602-1625. doi: 10.1111/1467-9566.13795. Epub 2024 Jun 8.
- Derived from this study: PubMed 38616276Greenhalgh T, Darbyshire JL, Lee C, Ladds E, Ceolta-Smith J. What is quality in long covid care? Lessons from a national quality improvement collaborative and multi-site ethnography. BMC Med. 2024 Apr 15;22(1):159. doi: 10.1186/s12916-024-03371-6.
- Derived from this study: PubMed 38456315Lee C, Greenwood DC, Master H, Balasundaram K, Williams P, Scott JT, Wood C, Cooper R, Darbyshire JL, Gonzalez AE, Davies HE, Osborne T, Corrado J, Iftekhar N, Rogers N, Delaney B, Greenhalgh T, Sivan M; LOCOMOTION Consortium. Prevalence of orthostatic intolerance in long covid clinic patients and healthy volunteers: A multicenter study. J Med Virol. 2024 Mar;96(3):e29486. doi: 10.1002/jmv.29486.
- Derived from this study: PubMed 36708608Mullard JCR, Kawalek J, Parkin A, Rayner C, Mir G, Sivan M, Greenhalgh T. Towards evidence-based and inclusive models of peer support for long covid: A hermeneutic systematic review. Soc Sci Med. 2023 Mar;320:115669. doi: 10.1016/j.socscimed.2023.115669. Epub 2023 Jan 14.
- Derived from this study: PubMed 35580970Sivan M, Greenhalgh T, Darbyshire JL, Mir G, O'Connor RJ, Dawes H, Greenwood D, O'Connor D, Horton M, Petrou S, de Lusignan S, Curcin V, Mayer E, Casson A, Milne R, Rayner C, Smith N, Parkin A, Preston N, Delaney B; LOCOMOTION consortium. LOng COvid Multidisciplinary consortium Optimising Treatments and servIces acrOss the NHS (LOCOMOTION): protocol for a mixed-methods study in the UK. BMJ Open. 2022 May 17;12(5):e063505. doi: 10.1136/bmjopen-2022-063505.
- Individual participant dataSharing planned: Undecided
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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.
Manoj Sivan, MD principal investigator
University of Leeds
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 COVID-19, run by University of Leeds 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 2 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: status not confirmed, as of the sponsor's last update on 3 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manoj Sivan, MD (01133922564, m.sivan@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Quality of Life Five Dimensions (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05057260, which also lists 8 linked publications.
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 3 Nov 2022.