protocolSection identificationModule nctId: NCT06305793, orgStudyIdInfo id: Pro00112597_A, secondaryIdInfos id: OTA-21-015G, type: OTHER, domain: NIH Grant to RTI; RTI subcontracting with DCRI, briefTitle: RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG), 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 Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs., conditionsModule conditions: Long COVID, conditions: Long Coronavirus Disease 2019 (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: 200, type: ESTIMATED, armsInterventionsModule interventions name: IVIG (intravenous immunoglobulin), interventions name: IVIG Placebo, interventions name: Coordinated Care, interventions name: 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 Patient-Reported Outcomes Measurement Information System (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 ( Serious Adverse Event) 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: All sites listed under NCT06305780, city: Durham, state: North Carolina, zip: 27710, country: United States, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False