Post-COVID-19 Postural Orthostatic Tachycardia Syndrome
Conditions
Brief summary
Proportion of participants no longer meeting diagnostic criteria of post-COVID POTS as measured by standardized standing test (ie, no longer experiencing HR increase of ≥ 30 bpm, in the absence of 20 mmHg decrease of SBP [orthostatic hypotension])
Detailed description
Change from baseline in orthostatic intolerance score of COMPASS-31, Change from baseline in COMPASS-31 total score, Change from baseline in heart rate increase within 10 minutes of standing test, Number of participants with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs and related serious TEAEs, Percentage of participants with TEAEs, related TEAEs, serious TEAEs and related serious TEAEs, Number of participants with electrocardiogram (ECG) abnormalities, Percentage of participants with ECG abnormalities, Change from baseline in ECG abnormalities
Interventions
Sponsors
CSL Behring LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants no longer meeting diagnostic criteria of post-COVID POTS as measured by standardized standing test (ie, no longer experiencing HR increase of ≥ 30 bpm, in the absence of 20 mmHg decrease of SBP [orthostatic hypotension]) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in orthostatic intolerance score of COMPASS-31, Change from baseline in COMPASS-31 total score, Change from baseline in heart rate increase within 10 minutes of standing test, Number of participants with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs and related serious TEAEs, Percentage of participants with TEAEs, related TEAEs, serious TEAEs and related serious TEAEs, Number of participants with electrocardiogram (ECG) abnormalities, Percentage of participants with ECG abnormalities, Change from baseline in ECG abnormalities | — |
Countries
Germany, Italy, Spain
Outcome results
None listed