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RECOVER-AUTONOMIC Platform Protocol
Sponsor: Kanecia Obie Zimmerman
Summary
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.
Official title: RECOVER-AUTONOMIC: A Platform Protocol for Evaluation of Interventions for Autonomic Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
381
Start Date
2024-03-11
Completion Date
2025-07-09
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
IVIG + Coordinated Care
Participants will receive IVIG for a duration of 9 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with IVIG administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through a care coordinator.
IVIG Placebo + Coordinated Care
Normal saline given intravenously will be the control (placebo) product. Blinding IV bag and tubing covers will be used for both IVIG and Placebo administration. Participants will receive IVIG placebo for a duration of 9 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with IVIG placebo administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through a care coordinator.
Ivabradine + Coordinated Care
Participants will receive Ivabradine for a duration of 3 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with ivabradine administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through care coordinator.
Ivabradine Placebo + Coordinated Care
The control (placebo) oral tablets will be similar to the study drug, ivabradine. The control packaging matches the packaging. Participants will receive Ivabradine placebo for a duration of 3 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with ivabradine placebo administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, feedback, nutrition counseling, motivation, education, and assisted care through care coordinator.
IVIG + Usual Care
Participants will receive IVIG for a duration of 9 months and usual non-pharmacologic care (control) for a duration of 3 months. This will be concurrent with scheduled IVIG administration.
IVIG Placebo + Usual Care
Normal saline given intravenously will be the control (placebo) product. The normal saline will be of similar formulation and appearance to IVIG. Participants will receive IVIG placebo for a duration of 9 months and usual non-pharmacologic care (control) for a duration of 3 months. This will be concurrent with scheduled IVIG placebo administration.
Ivabradine + Usual Care
Participants will receive Ivabradine for a duration of 3 months and usual non-pharmacologic care (control) for a duration of 3 months, concurrent with ivabradine administration.
Ivabradine Placebo + Usual Care
The control (placebo) oral tablets will be similar to the study drug, ivabradine. The control packaging matches the packaging. Participants will receive Ivabradine placebo for a duration of 3 months and usual non-pharmacologic care (control) for a duration of 3 months, concurrent with ivabradine placebo administration.
Locations (50)
East Alabama Medical Center - Appendix B Only
Opelika, Alabama, United States
Center for Complex Neurology - Appendix A & B
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences - Appendix A & B
Little Rock, Arkansas, United States
University of California San Diego - Appendix B Only
La Jolla, California, United States
Cedars Sinai Medical Center - Appendix A & B
Los Angeles, California, United States
Stanford University - Appendix B Only
Stanford, California, United States
University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B
Aurora, Colorado, United States
MedStar National Rehabilitation Hospital - Appendix B only
Washington D.C., District of Columbia, United States
University of Florida Health - Appendix A & B
Gainesville, Florida, United States
Lakeland Regional Medical Center - Appendix A & B
Lakeland, Florida, United States
Innovation Clinical Trials Inc.- Appendix A & B
Palmetto Bay, Florida, United States
Grady Memorial Hospital - Woodruff Memorial Research - Appendix A & B
Atlanta, Georgia, United States
Morehouse School of Medicine - Appendix A & B
Atlanta, Georgia, United States
Queens Medical Center - Appendix B Only
Honolulu, Hawaii, United States
Rush University Medical Center - Appendix B Only
Chicago, Illinois, United States
University of Illinois at Chicago - Appendix A & B
Chicago, Illinois, United States
NorthShore University HealthSystem - Evanston Hospital - Appendix B Only
Evanston, Illinois, United States
University of Iowa - Appendix A & B
Iowa City, Iowa, United States
University of Kansas Medical Center CTSU Fairway - Appendix A & B
Fairway, Kansas, United States
University of Kentucky Medical Center - Appendix A & B
Lexington, Kentucky, United States
University Medical Center New Orleans - Appendix A & B
New Orleans, Louisiana, United States
Johns Hopkins Hospital - Appendix A Only
Baltimore, Maryland, United States
Brigham and Women's Hospital - Appendix A Only
Boston, Massachusetts, United States
Henry Ford Hospital - Appendix A & B
Detroit, Michigan, United States
Mayo Clinic - Appendix A & B
Rochester, Minnesota, United States
University of Mississippi Medical Center - Appendix A & B
Jackson, Mississippi, United States
Washington University School of Medicine - Appendix B Only
St Louis, Missouri, United States
University at Buffalo - Appendix A & B
Buffalo, New York, United States
St. Lawrence Health Medical Campus - Appendix A & B
Canton, New York, United States
Columbia University Irving Medical Center - Appendix A & B
New York, New York, United States
Stony Brook University Hospital - Appendix A & B
Stony Brook, New York, United States
Montefiore Medical Center - Moses Campus - Appendix B
The Bronx, New York, United States
Duke University Hospital - Appendix A & B
Durham, North Carolina, United States
East Carolina University - Appendix B Only
Greenville, North Carolina, United States
Cleveland Clinic - Appendix A & B
Cleveland, Ohio, United States
University of Oklahoma Health Science Center - Oklahoma Clinical and Translational Science Institute - Appendix A & B
Oklahoma City, Oklahoma, United States
Oregon Health and Science University - Appendix A & B
Portland, Oregon, United States
Kent Hospital - Appendix A & B
Pawtucket, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
National Neuromuscular Research Institute - Appendix A & B
Austin, Texas, United States
Southwest Family Medicine Associates - Appendix A & B
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Texas Health Science Center at San Antonio - Appendix A & B
San Antonio, Texas, United States
Bateman Horne Center - Appendix B Only
Salt Lake City, Utah, United States
Vermont Lung Center, University of Vermont - Appendix B Only
Burlington, Vermont, United States
University of Virginia Health System, University Hospital - Appendix A & B
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital - Appendix A & B
Norfolk, Virginia, United States
Evergreen Hospital Medical Center - Appendix A & B
Kirkland, Washington, United States
Providence Medical Research Center - Appendix A & B
Spokane, Washington, United States
Marshall Health - University Physicians and Surgeons - Appendix A & B
Huntington, West Virginia, United States