Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965752
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-07-25
Brief Title:
RECOVER-NEURO Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
RECOVER-NEURO A Platform Protocol for Evaluation of Interventions for Cognitive Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection PASC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems for remote settings 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 potential interventions for PASC-mediated cognitive dysfunction The hypothesis is that PASC associated dysfunction in cognitive domains such as executive function and attention may be improved by interventions that selectively focus on enhancing those domains
This protocol is a prospective multi-center multi-arm randomized controlled platform trial evaluating potential interventions for PASC-mediated cognitive dysfunction The hypothesis is that PASC associated dysfunction in cognitive domains such as executive function and attention may be improved by interventions that selectively focus on enhancing those domains
Detailed Description:
Participants will be randomized to one of the intervention appendices that are actively enrolling at the time of randomization Intervention appendices may be added or removed according to adaptive design andor emerging evidence Various interventions will be studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OTA-21-015G | OTHER_GRANT | NIH grant to RTI RTI subcontracting with DCRI | None |