Post-COVID syndrome, Post-acute sequelae of SARS-CoV-2 infection
Conditions
Interventions
Not applicable.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Long-COVID patients • Age >= 18 years, 6 months • Presence of post-exertional malaise • Provided written informed consent Convalescent Controls • Age >= 18 years, 95% compared to functioning prior COVID-19 infection • Self-reported general good wellbeing • Provided written informed consent
Exclusion criteria
Exclusion criteria: Long-COVID patients • Unable or not willing to provide written informed consent • Unable to complete written questionnaires in Dutch • Unable to draw blood for study purposes • Diagnosis of dementia • Active treatment with hyperbaric oxygen treatment during study start • Alternative diagnosis that may explain clinical symptoms • Suffering from any pre-existing immune-driven disease or use of anti-inflammatory therapy of any kind (including NSAIDs and steroids) during the last 3 months • Suffering from diabetes mellitus, hypertension, severe mental conditions or use of anticoagulant treatment in the past 4 weeks. • No re-infection with COVID-19 in the past 3 months Convalescent Controls • Unable or not willing to provide written informed consent • Unable to complete written questionnaires in Dutch • Unable to draw blood for study purposes • Diagnosis of dementia • Genetically related to participating patients (e.g. brother/sister/parent) • Suffering from any immune-driven disease or use of anti-inflammatory therapy of any kind (including NSAIDs and steroids), including during the last 3 months • Suffering from diabetes mellitus, hypertension, severe mental conditions or use of anticoagulant treatment in the past 4 weeks. • Re-infection with SARS-CoV-2 in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I: Difference between groups (long-COVID versus control) in the change in microcirculatory Hb saturation (%) as determined by handheld sublingual reflective spectrophotometry before and after physical exercise (1 min sit to stand test). II: Difference between groups (long-COVID versus control) in plasma levels of VEGF-A. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease characterization Extensive disease characterization will be performed based on patient reported outcome measures (PROMs) collected online via Castor EDC: 1] Persisting symptoms and severity (corona symptom checklist) 2] Health-related quality of life (HRQoL, EQ5D) 3] Fatigue (Fatigue Assessment Scale, FAS) 4] Dyspnea (Modified Medical Research Council Dyspnea Scale, mMRC) 5] Cognitive failures in daily life (Cognitive failure questionnaire, CFQ) 6] Return to work (iMTA Productivity Cost Questionnaire, iPCQ) 7] Post-Exertional Malaise (modified sf-DSQ-PEM) 8] Postural orthostatic tachycardia syndrome (Malmo POTS symptom score) 9] Recovery status (Numeric scale and Likert scale)10] Functional capacity (FUNCAP55) Systemic oxygenation parameters (pulseoximetry) before and after exercise, difference between groups • SpO2 (%) Microcirculatory parameters (sublingual microcirculation): before and after exercise, difference between groups. • Total vessel density (TVD in mm/mm2) • Functional capillary density (FCD in mm/mm2) • Perfused vessel density (PPV in %) • Red blood cell velocity (RBCv in µm × s-) Peripheral tissue oxygenation (near infrared reflectance spectrophotometry) before and after exercise, difference between groups • Oxygen consumption derived by StO2 downslope (%/minute) during the ischemia phase of vascular occlusion test • Microvascular recruitment determined as the StO2 upslope (%/minute) during the reperfusion phase of vascular occlusion test Angiogenesis markers, difference between groups: • Vascular transformation markers (HIF-1, ANGPT-1) Endothelial activation markers, difference between groups: • Serum markers of endothelial cell activation (E-selectin, VCAM-1, ICAM-1, P-selectin) Inflammation parameters, difference between groups • Leukocytes in the sublingual microcirculation (number of leukocytes per capillary-postcapillary venule unit per image sequence) • Serum markers of inflammation activation (Il-6, sCD25 (sIL-2Ra), T | — |
Countries
Netherlands
Contacts
Public ContactM.E. Hellemons
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed