RECOVER-AUTONOMIC is a placebo-controlled RCT testing IVIG, ivabradine, and coordinated care effects on orthostatic intolerance symptoms in Long COVID POTS patients.
Do intravenous immunoglobulin, ivabradine, or coordinated nonpharmacologic care improve orthostatic intolerance symptoms in adults with Long COVID postural orthostatic tachycardia syndrome?
The RECOVER-AUTONOMIC trial is a platform RCT designed to evaluate the efficacy of IVIG, ivabradine, and coordinated nonpharmacologic care for treating POTS in adults with Long COVID.
Absolute Event Rate: 0% vs 0%
• NIH-sponsored platform RCT in Long COVID postural orthostatic tachycardia syndrome • Tests intravenous immunoglobulin and ivabradine vs placebo • Factorial design includes coordinated care vs usual care • Primary endpoint: change in measured orthostatic intolerance symptoms Post‑acute sequelae of SARS‑CoV‑2 infection (Long COVID) affect a substantial proportion of individuals, and among the many reported symptom clusters, autonomic dysfunction, particularly postural orthostatic tachycardia syndrome (POTS), represents an important subset. The Researching COVID to Enhance Recovery Clinical Trials (RECOVER-CT) initiative developed by the National Institutes of Health included a platform trial (RECOVER-AUTONOMIC) designed to assess the safety, tolerability, and efficacy of three interventions — (1) coordinated nonpharmacologic care, (2) pharmacotherapy with intravenous immunoglobulin (IVIG), and (3) pharmacotherapy with ivabradine — in treating POTS in adults with Long COVID. RECOVER-AUTONOMIC is a multicenter, randomized, double-blinded, placebo-controlled, platform trial employing a flexible, adaptive design. Participants are randomized to IVIG or ivabradine with matching placebo, and (in a factorial design) to either coordinated nonpharmacologic care or usual care. The primary endpoint is the change in orthostatic intolerance symptoms measured by the Orthostatic Hypotension Questionnaire/Orthostatic Intolerance Questionnaire from baseline to the end of intervention. Secondary endpoints include quality of life, functional performance, symptom burden, and safety. Exploratory endpoints include autonomic function testing, wearable sensor data, and longitudinal biomarker profiling. RECOVER-AUTONOMIC seeks to determine the benefits and risks of IVIG and of ivabradine, as well as of coordinated nonpharmacologic care, for the treatment of POTS in Long COVID. Results from this trial will offer the largest source of evidence to help guide the medical care of this population. ClinicalTrials.gov – Platform: NCT06305780; Appendix A (intravenous immunoglobulin): NCT06305793; Appendix B (ivabradine): NCT06305806. Protocol available at https://trials.recovercovid.org/autonomic .
Fudim et al. (Sun,) reported a other. RECOVER-AUTONOMIC is a placebo-controlled RCT testing IVIG, ivabradine, and coordinated care effects on orthostatic intolerance symptoms in Long COVID POTS patients.