Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597682
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
A Randomized Controlled Basket Study Protocol for Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Basket Study Protocol for Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RISE
Brief Summary:
This study is a prospective randomized controlled basket trial Patients diagnosed with Post-Acute Sequelae of SARS-CoV-2 InfEction who meet the inclusion and exclusion criteria are recruited and divided into four subgroups cardiovascular symptoms group respiratory symptoms group neurological symptoms group and fatigue group
Each subgroup is randomly divided into an experimental group and a control group Patients in the experimental group receive conventional treatment plus hormone intervention therapy or hormone intervention therapy alone while subjects in the control group receive conventional treatment or placebo control as detailed in the intervention methods section below Subjects in each subgroup undergo clinical medical record data collection laboratory tests and imaging examinations at specified time points as well as records of adverse events and side effects
Each subgroup is randomly divided into an experimental group and a control group Patients in the experimental group receive conventional treatment plus hormone intervention therapy or hormone intervention therapy alone while subjects in the control group receive conventional treatment or placebo control as detailed in the intervention methods section below Subjects in each subgroup undergo clinical medical record data collection laboratory tests and imaging examinations at specified time points as well as records of adverse events and side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None