Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524739
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Double-blind Randomized Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Double-blind Randomized Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of IgPro20 Subcutaneous Immunoglobulin HIZENTRA in Post-COVID-19 Postural Orthostatic Tachycardia Syndrome POTS
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This is a prospective phase 3 multicenter double-blind randomized placebo-controlled study to investigate the efficacy safety and pharmacokinetics PK of repeat doses of IgPro20 in participants with post SARS-CoV-2 infection 2019 postural orthostatic tachycardia syndrome post-Coronavirus Disease 2019 COVID-19 POTS post-COVID-POTS
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