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Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in post-COVID-19 POTS
EU CTIS ID: 2023-508744-22-00
What this study is testing
The primary objective of this study is to evaluate the efficacy of IgPro20 in comparison with placebo in adults with post-COVID POTS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Provide written informed consent and be willing and, in the opinion of the investigator, able to adhere to all protocol requirements.
- 2. Males and females aged ≥ 18 at the time of providing written informed consent.
- 3. Diagnosis of post-COVID POTS, defined by both a preceding COVID-19 infection based on confirmed historical documentation and onset of POTS symptoms developing within 4 months after COVID-19 infection as defined per consensus criteria.
- 4. COMPASS-31 score of at least 40 at the Screening visit.
- 5. Positive confirmatory standardized standing test (ie, HR increase of ≥ 30 bpm [≥ 40 bpm for participants aged 18 to 19 years] within 10 minutes in the absence of orthostatic hypotension) at the Screening visit.
You likely can't join if
- 1. Treatment with Immunoglobulin G (IgG) or plasmapheresis within 12 weeks before Screening
- 2. Symptoms and / or diagnosis of or receiving treatment for POTS before COVID-19 infection
- 3. Prior diagnosis of or receiving current treatment at Screening for the following conditions (unless onset was related to the inciting POTS-associated COVID-19 infection): certain neurologic, autoimmune, endocrine, cardiac, or other disorders, and pre-existing psychiatric disorders.
- 4. Presence of active infections, including human immunodeficiency virus infection, hepatitis B, hepatitis C, active SARS-CoV-2 infection, or any uncontrolled systemic infection
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.