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About
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.
Full description
The hypothesis is that some of the autonomic dysfunction symptoms are immune-mediated, so immunotherapy and other applicable therapies will result in improvement in autonomic symptoms.
Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Additional Appendix B (Ivabradine Sub-study) Level Inclusion Criteria:
Exclusions Criteria:
Additional Appendix B (Ivabradine Sub-study) Level Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
180 participants in 4 patient groups
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Central trial contact
Barrie L Harper, BSMT(ASCP)PMP; Orshi Moy
Data sourced from clinicaltrials.gov
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