RECOVER-AUTONOMIC Clinical Trial
RECOVER-AUTONOMIC is focused on autonomic dysfunction symptoms related to Long COVID, such as fast heart rate, dizziness, and fatigue. These symptoms are related to damage to nerves that are part of the autonomic nervous system, which controls automatic body functions like heartbeat and blood pressure.
This web page provides information about the RECOVER-AUTONOMIC study. Clinical research sites will contact potential participants from their surrounding communities. Sites will be listed in the study record on clinicaltrials.gov as they begin enrolling participants.
About 380 total participants will be enrolled in this study
What is being studied?
RECOVER-AUTONOMIC is studying possible treatments for adults who have an autonomic nervous system disorder, called Postural Orthostatic Tachycardia Syndrome (POTS), related to Long COVID. This study will include adults who had COVID and who still have 1 or more of these autonomic dysfunction symptoms when they stand up from sitting or lying down:
Fast Heart Rate
Dizziness
Fatigue
Participants will be assigned to 1 of 2 groups to study a repurposed drug as a possible treatment for these Long COVID symptoms. Repurposed drugs are medicines that are already approved by the U.S. Food and Drug Administration for the treatment of other health conditions.
The repurposed drugs being studied in RECOVER-AUTONOMIC are:
In addition to the study drugs IVIG and ivabradine, RECOVER-AUTONOMIC is studying possible coordinated non-drug treatments, like making diet changes and wearing a compression belt around the stomach.
What do we hope to learn?
Results from this study will help us learn if the study drugs and lifestyle changes are safe and improve POTS symptoms related to Long COVID. The research team will use a variety of tests, including physical ability exams and participant surveys, to determine if the study treatments help people feel better by improving their daily functioning.
After the study is complete and the data have been analyzed, we will share the overall study results on this website.
What happens during this study?
RECOVER-AUTONOMIC participants will be asked to:
Visit the study clinic at least 4 times
Complete lab tests, physical ability tests, and autonomic nervous system function tests
Take an active study drug or placebo, provided at no cost
Wear a fitness tracker to record heart rate and daily activity
Answer surveys about how they are feeling
Depending on which study group participants are assigned to, they will be in the study for about 6 months to 1 year. Participants may have additional study visits and activities specific to their assigned group.
How are participants assigned to a study group?
After answering questions about their symptoms, medications, and health history, participants who are a good fit for this study will be assigned to either Study Group A or Study Group B.
Some study clinics may not have the equipment to provide both study drugs – participants at those sites will be assigned to the available study drug group. In addition to an active study drug or placebo group, participants will be assigned by chance to 1 of these groups:
- Coordinated Non-Drug Care: participants in this group will have weekly calls with a care coordinator for 3 months to discuss their completion of study activities.
- Usual Non-Drug Care: participants in this group will receive the healthcare they would normally receive, such as general recommendations for diet and lifestyle changes.
Who is leading this study?
The RECOVER-AUTONOMIC team includes patient representatives, community leaders, doctors, and researchers from across the country. Community partners help make sure the study includes and benefits people most affected by Long COVID.
Learn moreLearn 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 or Study Group B.
