protocolSection identificationModule nctId: NCT06305780, orgStudyIdInfo id: Pro00112597, secondaryIdInfos id: OTA-21-015G, type: OTHER, domain: NIH Grant to RTI; RTI subcontracting with DCRI, briefTitle: RECOVER-AUTONOMIC Platform Protocol, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Kanecia Obie Zimmerman, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Long COVID, conditions: Long Covid19, conditions: Long Covid-19, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 380, type: ESTIMATED, armsInterventionsModule interventions name: IVIG + Coordinated Care, interventions name: IVIG Placebo + Coordinated Care, interventions name: Ivabradine + Coordinated Care, interventions name: Ivabradine Placebo + Coordinated Care, interventions name: IVIG + Usual Care, interventions name: IVIG Placebo + Usual Care, interventions name: Ivabradine + Usual Care, interventions name: Ivabradine Placebo + Usual Care, outcomesModule primaryOutcomes measure: Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score, secondaryOutcomes measure: Change in Composite Autonomic Symptoms Score 31 (COMPASS-31), secondaryOutcomes measure: Change in Malmo POTS Symptom Score, secondaryOutcomes measure: Change in Active Stand Test, secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in heart rate (HR), secondaryOutcomes measure: Change in 6-min Walk Test, secondaryOutcomes measure: Change in PROMIS-29 + 2 Questionnaire, secondaryOutcomes measure: Change in step count as measured by a wearable device, secondaryOutcomes measure: Change in heart rate as measured by a wearable device, secondaryOutcomes measure: Proportion of participants who experience individual SAEs, secondaryOutcomes measure: Proportion who experience any one or more SAEs, secondaryOutcomes measure: Incidence of SAEs leading to discontinuation, secondaryOutcomes measure: Incidence of Events of Special Interest (ESIs), otherOutcomes measure: Changes in Autonomic Function Testing, otherOutcomes measure: Change in Vanderbilt Orthostatic Symptoms Score (VOSS), otherOutcomes measure: Change in PASC Symptom Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Rush University Medical Center - Appendix A & B, city: Chicago, state: Illinois, zip: 60612, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: NorthShore University HealthSystem - Evanston Hospital - Appendix B Only, city: Evanston, state: Illinois, zip: 60201, country: United States, geoPoint lat: 42.04114, lon: -87.69006, locations facility: University of Kansas Medical Center CTSU Fairway - Appendix A & B, city: Fairway, state: Kansas, zip: 66205, country: United States, geoPoint lat: 39.02223, lon: -94.6319, locations facility: St. Lawrence Health Medical Campus - Appendix A & B, city: Canton, state: New York, zip: 13617, country: United States, geoPoint lat: 44.59562, lon: -75.16909, locations facility: Sentara Norfolk General Hospital - Appendix A and B, city: Norfolk, state: Virginia, zip: 23507, country: United States, geoPoint lat: 36.84681, lon: -76.28522, locations facility: Providence Medical Research Center - Appendix A & B, city: Spokane, state: Washington, zip: 99204, country: United States, geoPoint lat: 47.65966, lon: -117.42908, hasResults: False