Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404073
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-03
Brief Title:
RECOVER-ENERGIZE Platform Protocol_Appendix B Structured Pacing PEM
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
RECOVER-ENERGIZE A Platform Protocol for Evaluation of Interventions for Exercise Intolerance in Post-Acute Sequelae of SARS-CoV-2 Infection PASC
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 is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes
This protocol is a prospective multi-center multi-arm randomized controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise PEM as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection PASC
The focus of this protocol is to assess interventions that can improve exercise capacity daily activities tolerance and quality of life in patients with PASC
This protocol is a prospective multi-center multi-arm randomized controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise PEM as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection PASC
The focus of this protocol is to assess interventions that can improve exercise capacity daily activities tolerance and quality of life in patients with PASC
Detailed Description:
Study 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 intervention appendices may be added or removed according to adaptive design andor emerging evidence
The platform protocol enrolls participants who meet study eligibility criteria After completing initial screening assessments eligible participants are assigned to one of the study intervention appendices that are actively enrolling Participants must meet certain criteria within a specific appendix in order to be included in that appendix Once assigned to an appendix eligible participants are randomized to either the study intervention group or a control group
The platform protocol enrolls participants who meet study eligibility criteria After completing initial screening assessments eligible participants are assigned to one of the study intervention appendices that are actively enrolling Participants must meet certain criteria within a specific appendix in order to be included in that appendix Once assigned to an appendix eligible participants are randomized to either the study intervention group or a control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| NHLBI Grant to RTI | OTHER_GRANT | RTI subcontracting with DCRI | httpsreporternihgovquickSearchOT2HL156812 |
| OT2HL156812 | NIH | None | None |