Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04646044
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2020-11-14
Brief Title:
A Placebo Controlled Trial of Bempegaldesleukin BEMPEG NKTR-214 With Standard of Care in Patients With Mild COVID-19
Sponsor:
Nektar Therapeutics
Organization:
Nektar Therapeutics
Study Overview
Official Title:
A Phase 1b Multicenter Randomized Double-Blind Placebo-Controlled Trial of Bempegaldesleukin BEMPEG NKTR-214 Plus Standard of Care Versus Placebo Plus Standard of Care in Adults With Mild COVID-19
Status:
COMPLETED
Status Verified Date:
2024-03
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:
The main purpose of this phase-1b multicenter randomized double-blind placebo-controlled trial is to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of bempegaldesleukin BEMPEG NKTR-214 in combination with standard of care SOC in adult patients with mild COVID-19 coronavirus disease 2019 The trial will also define the recommended phase 2 dose RP2D of bempegaldesleukin in patients with mild COVID-19
Detailed Description:
None
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