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Study on the Effectiveness of Human Normal Immunoglobulin for Adults with Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Postural Orthostatic Tachycardia Syndrome (POTS), which can occur after a COVID-19 infection. POTS is a disorder that affects blood flow, leading to symptoms like dizziness and a rapid increase in heart rate when standing up. The study will evaluate the effectiveness and safety of a treatment called IgPro20, also known as Hizentra, which is a solution for injection containing human normal immunoglobulin. This treatment is compared to a placebo to see if it can help improve the symptoms of post-COVID POTS.

The purpose of the study is to determine if IgPro20 can effectively reduce the symptoms of POTS in adults who have developed this condition after recovering from COVID-19. Participants in the study will receive either the IgPro20 treatment or a placebo. The study will monitor changes in symptoms and any side effects over a period of time. The treatment is administered through a subcutaneous injection, which means it is injected under the skin.

Throughout the study, participants will undergo various assessments to track their progress. These assessments include measuring changes in heart rate and evaluating symptoms related to POTS. The study aims to see if participants no longer meet the diagnostic criteria for POTS after treatment. Additionally, the study will monitor any adverse effects that may occur during the treatment period. The goal is to provide valuable information on the potential benefits of IgPro20 for individuals suffering from post-COVID POTS.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants are required to provide written informed consent. This confirms understanding of the study and willingness to follow all study requirements.
Participants must be at least 18 years old and have a diagnosis of post-COVID-19 postural orthostatic tachycardia syndrome (POTS).
Step 2
Initial assessment
An initial assessment is conducted to confirm eligibility. This includes a standardized standing test to measure heart rate (HR) increase and a COMPASS-31 questionnaire to evaluate symptoms.
The standing test checks for an increase in HR of at least 30 beats per minute (bpm) within 10 minutes without a significant drop in blood pressure.
Step 3
Treatment phase
Participants are randomly assigned to receive either the study medication, IgPro20 (Hizentra), or a placebo. This is a double-blind study, meaning neither participants nor researchers know who receives the medication or placebo.
The medication is administered as a subcutaneous injection, which means it is injected under the skin. The dosage is 200 mg/ml, and the frequency and duration of administration are determined by the study protocol.
Step 4
Ongoing monitoring
Throughout the study, participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes repeated standing tests and COMPASS-31 questionnaires.
Participants are also monitored for any side effects or adverse events, which are any unwanted or unexpected health problems that occur during the study.
Step 5
Final assessment
At the end of the study, a final assessment is conducted to determine if participants no longer meet the diagnostic criteria for post-COVID-19 POTS.
The final assessment includes a standardized standing test and a review of any changes in symptoms or health status.

Who can join the trial?

5 criteria

Provide written consent to participate in the study and be willing and able to follow all study requirements.
Be a male or female aged 18 years or older.
Have a diagnosis of post-COVID POTS (Postural Orthostatic Tachycardia Syndrome), which means you had a COVID-19 infection and developed POTS symptoms within 4 months after the infection.
Have a COMPASS-31 score of at least 40 at the screening visit. This is a questionnaire that measures symptoms related to the autonomic nervous system.
Have a positive result on a standardized standing test at the screening visit. This means your heart rate increases by at least 30 beats per minute (or 40 beats per minute if you are aged 18 to 19) within 10 minutes of standing, without a drop in blood pressure.

Who cannot join the trial?

3 criteria

Patients who are not adults cannot participate. This means you must be 18 years or older.
Patients who do not have Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS) cannot participate. POTS is a condition where your heart rate increases significantly when you stand up, causing symptoms like dizziness or fainting.
Patients who are part of a vulnerable population cannot participate. This generally refers to groups who may need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Hospital Clinic De Barcelona
Barcelona, Spain
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

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Investigated drugs

IgPro20 (HIZENTRA®) is a type of medication known as subcutaneous immunoglobulin. It is used to help boost the immune system by providing antibodies that the body may be lacking. In this clinical trial, IgPro20 is being tested to see if it can help people who have developed a condition called Postural Orthostatic Tachycardia Syndrome (POTS) after having COVID-19. POTS is a disorder that affects blood flow and can cause symptoms like dizziness and a rapid heartbeat when standing up. The goal of using IgPro20 in this study is to see if it can improve these symptoms and help patients feel better.

What is already known about the treatment

Hizentra – Hizentra is administered as a subcutaneous injection, meaning it is given under the skin. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness and safety for treating Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS). This medication is primarily used to help manage symptoms in individuals with this condition, which affects heart rate and blood flow. At the molecular level, Hizentra works by providing immunoglobulins, which are proteins that help the immune system function properly. It is classified as an immunoglobulin therapy.

Investigated diseases

Post-COVID-19 Postural Orthostatic Tachycardia Syndrome – This condition is characterized by an abnormal increase in heart rate that occurs after sitting up or standing. It often follows a COVID-19 infection and involves symptoms such as dizziness, lightheadedness, and palpitations. The syndrome is a form of dysautonomia, where the autonomic nervous system does not function properly. As individuals stand, their heart rate increases significantly, but without a corresponding drop in blood pressure. This can lead to feelings of fatigue and difficulty concentrating. Over time, symptoms may fluctuate in intensity and can be triggered by various factors such as dehydration or prolonged standing.