Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802083
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2021-10-04
First Post:
2021-02-17
Brief Title:
COVID-19 Soliris Expanded Access Protocol
Sponsor:
Alexion Pharmaceuticals Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
SOLIRIS Eculizumab for the Treatment of Participants With Coronavirus Disease 2019 COVID-19 - An Expanded Access Protocol
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2021-09
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:
This protocol provides participants with COVID-19 access to Soliris
Detailed Description:
This is an open-label multicenter expanded access protocol that will provide access to Soliris for participants diagnosed with severe acute respiratory syndrome coronavirus 2 SARS-COV-2 infection with a clinical presentation consistent with COVID-19 associated organ injury such as acute respiratory distress syndrome stroke or acute renal failure Participants who qualify for emergency treatment whether in an inpatient or outpatient setting will be offered the opportunity to receive up to 7 infusions of Soliris over approximately 4 weeks
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