drugset / Trial / NCT06305793

RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)

NCT06305793 ↗

Phase 2 Active not recruiting 200 enrolled Kanecia Obie Zimmerman
RandomizedParallel-groupTriple-blindTreatment

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 Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

Timeline

Start
2024-03-11
Primary completion
2026-03-23
Completion
2026-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Gamunex Protein / enzyme biologic 2 g/kg Intravenous

Indications