Long COVIDPREPP-19NCT06394921
Cardiopulmonary Exercise Tests in Patients With Long COVID
An observational study of Long COVID and COVID Long-Haul, run by Sheffield Hallam University at 5 sites in 3 countries.
Trial summary
The value of clinical cardiopulmonary exercise testing (CPET) within healthcare settings has been established in the last decade. CPET methods remain highly relevant in the COVID-19 endemic phase and should be used to assess those recovering from COVID-19 (SARS-CoV-2) infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID, COVID Long-Haul
- What is being tested?
- 2 day cardiopulmonary exercise test
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 1 Mar 2023to 30 Apr 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be assessed according to the eligibility criteria and recruited directly from Long COVID Clinics in the UK (Derbyshire Community Health Services, Sheffield Teaching Hospitals NHS Foundation Trust and Northumbria NHS Trust), the University of Illinois Post-COVID-19 Clinic, (Chicago, USA) and the Ramiah Medical Centre Post COVID Centre (Bangalore, India). Long COVID patients will be assessed according to the eligibility criteria and recruited following referral or contact with a long COVID clinic or having suspected or confirmed long COVID. Social media and targeted recruitment from established pages will be used to advertise the opportunity to engage with the trial for those in proximity
Who may be able to join
- • Aged 18 to 65 years old
- Diagnosed with COVID-19
- Still suffering from symptoms of COVID-19, 3 months after initial infection
- Sufficient English language comprehension and cognitive ability to understand the study protocol, give informed consent and follow instructions.
Who cannot join
- • <18 years of age
- Admitted to or received treatment from Intensive Care Units
- Unconfirmed COVID-19 test diagnosis
- Unable to understand verbal or written information in English
- Achieving a grade 0 or 1 on the PCFS.
- Unstable angina
Show all 19Show fewer
- Uncontrolled hypertension, that is, resting systolic blood pressure (SBP) >180mmHg, or resting diastolic blood pressure (BP) (DBP) >110mmHg
- Orthostatic blood pressure drop of >20 mmHg with symptoms
- Significant aortic stenosis (aortic valve area 120 bpm)
- Acute pericarditis or myocarditis
- Decompensated HF
- Third degree (complete) atrioventricular (AV) block without pacemaker
- Recent embolism
- Acute thrombophlebitis
- Resting ST segment displacement (>2 mm)
- Uncontrolled diabetes mellitus
- Severe orthopaedic conditions that would prohibit exercise
- Other metabolic conditions, such as acute thyroiditis, hypokalaemia, hyperkalaemia or hypovolaemia (until adequately treated)
- Severe grade 3 rejection (cardiac transplantation recipients Appendix N).
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom3 sites
University of Derby
Derby, Derbyshire
Northumbria University
Newcastle upon Tyne
Sheffield Hallam University
Sheffield, South Yorkshire
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60607
About this study
Official title: Interrogative Approaches Identify Causes of Physical Impairment in Those Affected by Post COVID-19 Morbidity (Long COVID) - an International Multicenter Observational Study
The value of clinical cardiopulmonary exercise testing (CPET) within healthcare settings has been established in the last decade. CPET methods remain highly relevant in the COVID-19 endemic phase and should be used to assess those recovering from COVID-19 (SARS-CoV-2) infection. This diagnostic tool could play an integral role in disease prognostication and evaluate the integrative response to incremental exercise. Date from such assessments can enable practitioners to characterise cardio-respiratory fitness and identify reasons for physical impairment or abnormal cardio-respiratory function. More than 50% of patients admitted to hospital will experience cardiorespiratory issues and significant morbidity during their recovery and will require significant rehabilitative support. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function. Current approaches to rehabilitation are being developed on existing knowledge from Severe Acute Respiratory Syndrome (SARS) and Acute Respiratory Distress Syndrome (ARDS) related illness. These provide important insight but do not provide insight into the novel challenges provided by COVID-19.
- Conditions
- Long COVID, COVID Long-Haul
- Being tested
- 2 day cardiopulmonary exercise test
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 day cardiopulmonary exercise testProcedure or surgery
Consecutive day 2 day CPET and follow up for 7 days for subjective feelings/fatigue.
| Study group | Role | What they receive |
|---|---|---|
| People with Long COVID | Eligibility
* Aged 18 to 65 years old
* Diagnosed with COVID-19
* Still suffering from symptoms and experiencing functional limitations beyond 3 months after initial COVID-19 infection (quantified as PCFS grade 1 or greater).
* Sufficient English language comprehension and cognitive ability to understand the study protocol, give informed consent and follow instructions. Receives: Procedure: 2 day cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Exercise Test- Rate of Oxygen Utilisation
Rate of Oxygen Utilisation (VO2; l/min)
Measured: During CPET1 and CPET2
Cardiopulmonary Exercise Test- Rate of carbon dioxide production
Rate of Carbon Dioxide Production (VCO2; l/min)
Measured: During CPET1 and CPET2
Cardiopulmonary Exercise Test- Respiratory Exchange Ratio
Respiratory Exchange Ratio (VO2/VCO2)
Measured: During CPET1 and CPET2
Cardiopulmonary Exercise Test: Maximal Rate of Oxygen Utilisation
Maximal Rate of Oxygen Utilisation per kg body mass (VO2max; ml/kg/min)
Measured: During CPET1 and CPET2
Cardiopulmonary Exercise Test- Respiratory Threshold
Respiratory Threshold breath by breath (l/min)
Measured: During CPET1 and CPET2
Cardiopulmonary Exercise Test- Minute Ventilation
Minute Ventilation using breath by breath (l/min)
Measured: During CPET1 and CPET2
Cardiopulmonary Exercise Test- Blood lactate
Blood Lactate Concentration from fingertip (mmol/l)
Measured: During CPET1 and CPET2
Prevalence of symptoms of post exertional Malaise
Symptom Profile post exercise protocols- Questionnaire
Measured: 7 days post exercise
Secondary outcomes (10)
Blood biomarkers of Inflammation- IL-6
Concentration of Interleukin 6
Measured: Day 1 and Day 2
Blood biomarkers of Inflammation- IL-1
Concentration of Interleukin 1
Measured: Day 1 and Day 2
Blood biomarkers of Inflammation- Microclots
Number of Microclots
Measured: Day 1 and Day 2
Blood biomarkers of Inflammation- D-Dimer
D-Dimer Concentration
Measured: Day 1 and Day 2
Blood biomarkers of Inflammation- CRP
C-Reactive protein Concentration
Measured: Day 1 and Day 2
Echocardiogram
12 lead echocardiogram.
Measured: Baseline, Day 1 and Day 2
Resting Systolic Blood Pressure
Systolic Blood Pressure at Rest (mmHg)
Measured: Baseline, Day 1 and Day 2
Resting Diastolic Blood Pressure
Diastolic Blood Pressure at Rest (mmHg)
Measured: Baseline, Day 1 and Day 2
Exercise Diastolic Blood Pressure
Diastolic Blood Pressure During Exercise (mmHg)
Measured: Baseline, Day 1 and Day 2
Exercise Systolic Blood Pressure
Systolic Blood Pressure During Exercise (mmHg)
Measured: Baseline, Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Mar 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- MS Ramaiah Medical College & Hospitals, University of Illinois Chicago, University of Nottingham, Northumbria University, King's College London, University of Derby
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394921
- Sponsor's protocol ID
- PREPP19
- Acronym
- PREPP-19
- Status last verified
- Aug 2024
- First submitted
- 26 Mar 2024
- Last updated
- 22 Aug 2024
- 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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrogative Approaches Identify Causes of Physical Impairment in Those Affected by Post COVID-19 Morbidity (Long COVID) - an International Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT06394921
- Acronym / sponsor ID
- PREPP-19 / PREPP19
- Conditions
- Long COVID, COVID Long-Haul
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- MS Ramaiah Medical College & Hospitals, University of Illinois Chicago, University of Nottingham, Northumbria University, King's College London, University of Derby
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 1 May 2024 (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 value of clinical cardiopulmonary exercise testing (CPET) within healthcare settings has been established in the last decade. CPET methods remain highly relevant in the COVID-19 endemic phase and should be used to assess those recovering from COVID-19 (SARS-CoV-2) infection. This diagnostic tool could play an integral role in disease prognostication and evaluate the integrative response to incremental exercise. Date from such assessments can enable practitioners to characterise cardio-respiratory fitness and identify reasons for physical impairment or abnormal cardio-respiratory function. More than 50% of patients admitted to hospital will experience cardiorespiratory issues and significant morbidity during their recovery and will require significant rehabilitative support. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function. Current approaches to rehabilitation are being developed on existing knowledge from Severe Acute Respiratory Syndrome (SARS) and Acute Respiratory Distress Syndrome (ARDS) related illness. These provide important insight but do not provide insight into the novel challenges provided by COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with Long COVID | – | Procedure: 2 day cardiopulmonary exercise testEligibility * Aged 18 to 65 years old * Diagnosed with COVID-19 * Still suffering from symptoms and experiencing functional limitations beyond 3 months after initial COVID-19 infection (quantified as PCFS grade 1 or greater). * Sufficient English language comprehension and cognitive ability to understand the study protocol, give informed consent and follow instructions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be assessed according to the eligibility criteria and recruited directly from Long COVID Clinics in the UK (Derbyshire Community Health Services, Sheffield Teaching Hospitals NHS Foundation Trust and Northumbria NHS Trust), the University of Illinois Post-COVID-19 Clinic, (Chicago, USA) and the Ramiah Medical Centre Post COVID Centre (Bangalore, India). Long COVID patients will be assessed according to the eligibility criteria and recruited following referral or contact with a long COVID clinic or having suspected or confirmed long COVID. Social media and targeted recruitment from established pages will be used to advertise the opportunity to engage with the trial for those in proximity
Key inclusion criteria (4 listed)
- • Aged 18 to 65 years old
Key exclusion criteria (19 listed)
- • <18 years of age
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 |
|---|---|---|
| 2 day cardiopulmonary exercise testConsecutive day 2 day CPET and follow up for 7 days for subjective feelings/fatigue. | Procedure or surgery | People with Long COVID |
Primary outcome
Cardiopulmonary Exercise Test- Rate of Oxygen Utilisation
Time frame: During CPET1 and CPET2
Rate of Oxygen Utilisation (VO2; l/min)
Cardiopulmonary Exercise Test- Rate of carbon dioxide production
Time frame: During CPET1 and CPET2
Rate of Carbon Dioxide Production (VCO2; l/min)
Cardiopulmonary Exercise Test- Respiratory Exchange Ratio
Time frame: During CPET1 and CPET2
Respiratory Exchange Ratio (VO2/VCO2)
Cardiopulmonary Exercise Test: Maximal Rate of Oxygen Utilisation
Time frame: During CPET1 and CPET2
Maximal Rate of Oxygen Utilisation per kg body mass (VO2max; ml/kg/min)
Cardiopulmonary Exercise Test- Respiratory Threshold
Time frame: During CPET1 and CPET2
Respiratory Threshold breath by breath (l/min)
Cardiopulmonary Exercise Test- Minute Ventilation
Time frame: During CPET1 and CPET2
Minute Ventilation using breath by breath (l/min)
Cardiopulmonary Exercise Test- Blood lactate
Time frame: During CPET1 and CPET2
Blood Lactate Concentration from fingertip (mmol/l)
Prevalence of symptoms of post exertional Malaise
Time frame: 7 days post exercise
Symptom Profile post exercise protocols- Questionnaire
10 secondary outcomes
Blood biomarkers of Inflammation- IL-6
Time frame: Day 1 and Day 2
Blood biomarkers of Inflammation- IL-1
Time frame: Day 1 and Day 2
Blood biomarkers of Inflammation- Microclots
Time frame: Day 1 and Day 2
Blood biomarkers of Inflammation- D-Dimer
Time frame: Day 1 and Day 2
Blood biomarkers of Inflammation- CRP
Time frame: Day 1 and Day 2
Echocardiogram
Time frame: Baseline, Day 1 and Day 2
Resting Systolic Blood Pressure
Time frame: Baseline, Day 1 and Day 2
Resting Diastolic Blood Pressure
Time frame: Baseline, Day 1 and Day 2
Exercise Diastolic Blood Pressure
Time frame: Baseline, Day 1 and Day 2
Exercise Systolic Blood Pressure
Time frame: Baseline, Day 1 and Day 2
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 22 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID and COVID Long-Haul, run by Sheffield Hallam University at 5 sites in 3 countries.
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 4 inclusion and 19 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, United States, India. 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?
Cardiopulmonary Exercise Test- Rate of Oxygen Utilisation (time frame: During CPET1 and CPET2). The study lists 8 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 22 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.