RECOVER-AUTONOMIC Study Group A: IVIG or Placebo
Participants in this study group will have an equal chance of receiving Gamunex-C, a form of intravenous immunoglobulin (IVIG), or saline placebo through intravenous (IV) infusion. IV infusions are a common way for healthcare providers to give fluid, medicines, or nutrients to patients.
In addition to receiving the active study drug or placebo, participants will be assigned by chance to receive coordinated non-drug care or usual non-drug care. Participants in Study Group A will be assigned to one of these groups:
What happens during this study?
Participants who receive IVIG or placebo will be asked to:
Participate in the study for about 1 year, including a 9-month treatment period and a follow-up visit 3 months later
Receive an IV infusion of the study drug or placebo for approximately 4 to 6 hours about once a week for 9 months (about 36 visits)
Give small skin samples to test for damage to nerves that control automatic body functions
For the first 3 months of the study, participants assigned to coordinated non-drug care will be asked to complete additional activities from home:
Check their heart rate and blood pressure
Eat a high-salt diet and drink a recommended amount of fluids per day
Wear a compression belt around their stomach while doing upright activities
Complete recommended physical activities
Keep a weekly log of their study activities
Receive weekly phone calls from the study team to discuss their coordinated care activities
Participants assigned to usual non-drug care will receive the healthcare they would normally receive, such as general recommendations for diet and lifestyle changes.
Learn more about RECOVER-AUTONOMIC
Click on the links below to learn more about the overall design of the study and what participants can expect if they are enrolled in Study Group A.
