Post-COVID-19 syndrome Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All participants: Aged 18-80 years Post-COVID-19 Syndrome participants: As per NICE guidelines https://www.nice.org.uk/guidance/ng188 Age and sex-matched controls@ 1. Positive SARS-CoV-2 antibody test before vaccination, or a positive COVID-19 PCR antigen swab test 2. Asymptomatic or symptoms <4 weeks after COVID-19 infection
Exclusion criteria
Exclusion criteria: All participants: 1. Body mass index =35 kg/m² 2. Pregnancy/breastfeeding women 3. Ongoing requirement of oxygen therapy 4. Taking antihypertensive, nitrate, steroid or immunosuppressant medication or medication 5. Major illness e.g., cancer, inflammatory disease (including vasculitis) or receiving palliative care 6. History of organ transplantation or are candidates for organ transplantation at the time of screening 7. History of Chronic Fatigue Syndrome prior to COVID-19 infection 8. Diagnosed cardiovascular disease (including current non-benign arrhythmia, chronic heart failure) 9. History of major psychiatric disorder including bipolar disorders, schizophrenia, schizoaffective disorder, major depression. 10. Diagnosis of structural lung disease (such as COPD or pulmonary fibrosis) 11. Diagnosed renal disease 12. Congenital or acquired neurological conditions (including dementia), language disorders, repeated or chronic pain conditions (excluding menstrual pain and minor sporadic headaches) 13. Diabetes Mellitus 14. Symptoms of febrile illness 2 weeks before experiment 15. Excessive alcohol consumption (>28 units/week) or use of illicit drugs 16. History of smoking within 2 months 17. Inability to understand instructions given in English 18. Surgery under general anaesthesia within 3 months 19. History of stroke 20. Heart transplant 21. Coronary revascularisation 22. Haemodialysis or peritoneal dialysis 23. Participating in another study for an investigational medicinal product Controls: Symptoms lasting >4 weeks following acute, confirmed, COVID-19 infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Level of muscle sympathetic nerve activity at rest is measured using microneurography at baseline 2. Level of MSNA during exercise is measured using microneurography following 6-12 minutes of ramped bike exercise tolerance testing 3. Hypoxic ventilatory response at rest will be calculated using spirometry, and ear oxygen saturation monitoring at baseline 4. Hypoxic ventilatory response during exercise will be calculated using spirometry, and ear oxygen saturation monitoring following 2 minutes of cycle ergometry at 30-40% VO2 peak and inhalation of medical grade nitrogen gas for 10-45 seconds 5. Change in the inflammatory biomarker IL-6 from rest to peak exercise will be measured using venous blood sampling at baseline and following 6-12 minutes of ramped exercise bike testing | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Spontaneous sympathetic baroreflex sensitivity will be measured using microneurography at baseline and following 6-12 minutes of ramped bike exercise tolerance testing 2. Spontaneous parasympathetic baroreflex sensitivity will be measured using 3-lead electrocardiogram (ECG) recording at baseline 3. 24-hour ambulatory blood pressure and office blood pressure will be measured using a 24-hour blood pressure cuff and office blood pressure cuff, respectively, continuously and at baseline, respectively 4. Beat-to-beat blood pressure variability at rest will be measured using a beat-to-beat finger blood pressure recording at baseline 5. Change in blood pressure (BP) in response to handgrip exercise will be measured using an office blood pressure cuff following 2 minutes of handgrip exercise 6. Sympathetic-respiratory coupling at rest will be measured using microneurography and a respiratory belt at baseline 7. Maximal oxygen uptake (VO2 peak) will be measured using a 12-lead ECG and spirometry following 3 minutes of pre-exercise baseline rest 8. Ventilatory efficiency (VE/VCO2) slope will be calculated from minute ventilation (VE) measurements at rest and VCO2 measurements following 2 minutes of ramped bike exercise tolerance testing 9. Rating of perceived exertion will be measured using the Borg scale after 6-12 minutes of ramped bike exercise tolerance testing 10. Change in heart rate from peak exercise to recovery will be measured using 3-lead ECG recording within the first 2 mins of stopping exercise 11. Blood pressure response to hypoxia at rest will be measured using an office blood pressure cuff at baseline 12. Blood pressure response to hypoxia during exercise will be measured using an automated brachial arm blood pressure cuff throughout cycle ergometry 13. Heart rate response to hypoxia at rest will be measured using 12-lead ECG monitoring at baseline 14. Heart rate response to hypoxia during exercise 12-lead ECG monitoring throughout 6-12 minutes of cycle | — |
Countries
England, United Kingdom
Contacts
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