Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810637
Status:
UNKNOWN
Last Update Posted:
2021-03-24
First Post:
2021-03-17
Brief Title:
A Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19
Sponsor:
PT Kalbe Genexine Biologics
Organization:
PT Kalbe Genexine Biologics
Study Overview
Official Title:
A Phase 2 Randomized Double Blinded Placebo Controlled Parallel Group Single Administration Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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 Phase 2 prospective randomized placebo-controlled double-blinded parallel group single administration multi-center study to assess the safety and efficacy of efineptakin alfa single treatment compared to placebo in elderly participants adults 50years with asymptomatic or mild COVID-19
Detailed Description:
The study consists of 2 parts
Part I - to identify the Recommended Phase 2 Dose RP2D compared to placebo in elderly participants adults 50 years with asymptomatic or mild COVID-19 These patients will be treated with 120 and 240 µgkg efineptakin alfa given on Day 1 Baseline respectively The study will evaluate the safety tolerability and pharmacodynamics variable ALC of efineptakin alfa against COVID-19
Part II - to assess the safety and efficacy of efineptakin alfa single treatment compared to placebo in elderly participants with asymptomatic or mild COVID-19
Part I - to identify the Recommended Phase 2 Dose RP2D compared to placebo in elderly participants adults 50 years with asymptomatic or mild COVID-19 These patients will be treated with 120 and 240 µgkg efineptakin alfa given on Day 1 Baseline respectively The study will evaluate the safety tolerability and pharmacodynamics variable ALC of efineptakin alfa against COVID-19
Part II - to assess the safety and efficacy of efineptakin alfa single treatment compared to placebo in elderly participants with asymptomatic or mild COVID-19
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