Double-blind, Randomized, Placebo-controlled Phase 3 study Evaluating Efficacy and Safety of IgPro20 (subcutaneous immunoglobulin, HIZENTRA®) in post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS)
Researchers are conducting a study to test a medicine called IgPro20 (Hizentra®) for individuals who developed a condition called Postural Orthostatic Tachycardia Syndrome (POTS) after having COVID-19. POTS can cause your heart rate to jump up significantly when you stand, leading to symptoms like dizziness, lightheadedness, and tiredness. The study wants to find out if Hizentra® can help people recover from these symptoms and no longer meet the diagnostic criteria for POTS. Participants will receive either the active medicine or a placebo (a dummy treatment without medicine) to see which is more effective and safe. This is a crucial step in finding better treatments for post-COVID POTS.
At a glance
What is this study about?
This study is investigating a new treatment for people who developed a condition called Postural Orthostatic Tachycardia Syndrome, or POTS, after having COVID-19. POTS is a condition that affects how your body controls your heart rate and blood pressure when you change position, especially when standing up. This can lead to symptoms like feeling dizzy, lightheaded, tired, or having your heart pound when you stand.
The medicine being tested is called IgPro20, also known as Hizentra®. It's given as an injection under the skin. The main goal of the study is to see if Hizentra® can help people with post-COVID POTS recover to the point where their heart rate no longer significantly increases when they stand, which is a key sign of POTS. They will compare Hizentra® to a 'placebo', which looks exactly like the medicine but doesn't actually contain any active drug. This helps researchers understand if any improvements are genuinely due to the medicine or other factors.
Researchers will also be looking at how people's daily symptoms change, their overall quality of life, and any side effects the medicine might cause. Finding an effective and safe treatment for post-COVID POTS is really important, as many people are still struggling with these symptoms long after their initial COVID-19 infection.
Key takeaways
- The study is for adults with POTS that developed after COVID-19.
- It tests an injected medicine called Hizentra® against a dummy treatment.
- The main goal is to see if the medicine reduces POTS symptoms when standing.
- Researchers will also check for side effects and how people feel overall.
- You might receive the active medicine or a placebo by chance.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
This study is looking for adults who are at least 18 years old. People of any gender can take part.
To be considered for the study, you must have been diagnosed with POTS after you had COVID-19. The study is specifically focused on this type of POTS.
The doctors and nurses involved in the study will do various checks to make sure the study is right for you and that you meet all the specific health requirements.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with POTS?
- Did your POTS start after you had COVID-19?
- Are you able to attend regular clinic appointments for the study?
What does participation involve?
If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to receive either the study medicine (Hizentra®) or a placebo (a dummy treatment). Neither you nor your study doctor will know which one you are receiving, which helps us get unbiased results.
The medicine or placebo will be given as injections under your skin. You will have regular visits to the clinic where doctors and nurses will monitor your health, take blood samples, and perform tests like a 'standing test'. This test measures your heart rate and blood pressure when you stand up to see how your body responds. You'll also be asked to complete questionnaires about your symptoms and how you are feeling. The study will last for a certain period, and there will be follow-up appointments to ensure your continued well-being.
Potential risks and benefits
Locations (3)
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What is POTS?
POTS stands for Postural Orthostatic Tachycardia Syndrome. It's a condition where your heart rate increases very quickly when you stand up, which can cause symptoms like dizziness, tiredness, and lightheadedness.
What does 'double-blind' mean?
Double-blind means that neither you nor your study doctor will know if you are receiving the actual medicine or a placebo (a dummy treatment). This helps ensure the study results are fair and accurate.
What is Hizentra®?
Hizentra® (IgPro20) is the name of the medicine being tested in this study. It's a type of treatment given by injection under the skin.
Will I have to pay to be in the study?
No, you will not have to pay to participate in the study, and all study-related treatments and assessments will be provided free of charge.
What is a 'standing test'?
A standing test simply involves measuring your heart rate and blood pressure while you are lying down and then again after you stand up. It helps doctors see how your body responds to changes in position.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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