Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT04796402
Status:
UNKNOWN
Last Update Posted:
2021-08-26
First Post:
2021-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess if a Medicine Called Bamlanivimab is Safe and Effective in Reducing Hospitalization Due to COVID-19
Sponsor:
Fraser Health
Organization:
Study Overview
Official Title:
A Pragmatic Eight Week Phase IV Study of Bamlanivimab/LY-CoV555 for Emergency Passive Immunity Against COVID-19
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
ACTIVE_NOT_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:
B-EPIC
Brief Summary:
The purpose of this research is to test whether a new medication called bamlanivimab is safe and effective at reducing the need for hospitalization due to COVID-19.
Detailed Description:
The study aims to examine the effectiveness of adding bamlanivimab provided by COVID-19 Clinics to standard of care on the incidence of hospitalization for high-risk patients infected with SARS-CoV2. Furthermore, we aim to test the effect on the following secondary outcomes: mortality and health-related quality of life and patients' satisfaction with care. We will also assess the recruitment rate from the three primary strategies for rapid identification and consent of eligible patients. The data from this study will inform clinical decisions about the use of bamlanivimab in high risk COVID-19 patients and the operational requirements necessary for research in passive immunity therapeutics.
Study Oversight
Has Oversight DMC:
True
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?:
True
Is an FDA AA801 Violation?: