Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305793
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-03-04
Brief Title:
RECOVER-AUTONOMIC Platform Protocol Appendix A IVIG
Sponsor:
Kanecia Obie Zimmerman
Organization:
Duke University
Study Overview
Official Title:
RECOVER-AUTONOMIC IVIG Randomized Trial of the Effect of IVIG Versus Placebo on Long COVID Symptoms
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OTA-21-015G | OTHER | NIH Grant to RTI RTI subcontracting with DCRI | None |