Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04860518
Status:
TERMINATED
Last Update Posted:
2023-07-21
First Post:
2021-04-22
Brief Title:
Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
Sponsor:
Faron Pharmaceuticals Ltd
Organization:
Faron Pharmaceuticals Ltd
Study Overview
Official Title:
A Phase II Multi-Center Double-Blind Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients With COVID-19 Infection
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The decision is based on changes in the pandemic and further weakening of the recruitment that will not enable a completion of the study in any reasonable time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIBISCUS
Brief Summary:
This double-blinded randomized study is being conducted to see if the investigational new drug called FP-1201-lyo - intravenous Interferon beta-1a hereafter IV IFN beta-1a can help patients recover more quickly from COVID-19 and prevent worsening of the condition To understand if IV IFN beta-1a can help treat patients with COVID-19 this study drug will be compared to dexamethasone
Study subjects will be treated daily with IV IFN beta-1a 10 μg or IV dexamethasone for 6 consecutive days while hospitalized and will undergo daily assessments while in hospital for a maximum of 28 days Study specific assessments will be collected at pre-dose Day 1 through Day 28 PD and PIM assessments in addition clinical routine assessments will be utilized for safety and efficacy assessments
Study subjects will be treated daily with IV IFN beta-1a 10 μg or IV dexamethasone for 6 consecutive days while hospitalized and will undergo daily assessments while in hospital for a maximum of 28 days Study specific assessments will be collected at pre-dose Day 1 through Day 28 PD and PIM assessments in addition clinical routine assessments will be utilized for safety and efficacy assessments
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