Study on the Effectiveness of Human Normal Immunoglobulin for Adults with Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS)
This Phase 3 clinical trial is evaluating whether a treatment called IgPro20, also known as Hizentra, can help people who developed POTS after recovering from COVID-19. POTS is a disorder that affects blood flow and causes symptoms like dizziness and a rapid increase in heart rate when standing up.
Who can participate:
- Adults aged 18 years or older
- People diagnosed with post-COVID-19 POTS who developed symptoms within 4 months after their COVID-19 infection
- Participants must have a COMPASS-31 score of at least 40, which measures symptoms related to the autonomic nervous system
- Candidates must show a positive result on a standardized standing test, meaning their heart rate increases by at least 30 beats per minute (or 40 beats per minute for those aged 18 to 19) within 10 minutes of standing, without a significant drop in blood pressure
- Participants must be able to provide written consent and follow all study requirements
Who cannot participate:
- Anyone under 18 years of age
- People who do not have post-COVID-19 POTS
- Members of vulnerable populations who may need special protection or care
What the study involves:
This is a double-blind study, which means that neither the participants nor the researchers will know who is receiving the actual medication and who is receiving a placebo. Participants will be randomly assigned to one of these two groups. IgPro20 is administered as a subcutaneous injection, meaning it is injected under the skin at a dosage of 200 mg/ml.
Throughout the study, participants will undergo regular monitoring to assess how well the treatment is working and to check for any side effects. This includes repeated standing tests to measure heart rate changes and COMPASS-31 questionnaires to evaluate symptoms. The goal is to see if participants no longer meet the diagnostic criteria for POTS after treatment.
About the investigational drug:
IgPro20 (Hizentra) is a type of medication known as subcutaneous immunoglobulin. It works by providing antibodies that help boost the immune system. The medication contains human normal immunoglobulin, which are proteins that help the immune system function properly. In this trial, researchers are testing whether this treatment can reduce the symptoms of POTS in people who developed the condition after COVID-19 infection.
Germany
