Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865107
Status:
UNKNOWN
Last Update Posted:
2021-05-05
First Post:
2021-04-27
Brief Title:
Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-05
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:
CIRCA-19 RCT
Brief Summary:
This is a Phase 2 multicenter randomized 21 placebo-controlled trial to evaluate early signs of efficacy of allogeneic umbilical cord-derived UC mesenchymal stromal cells MSCs in patients with COVID-19 and Acute Respiratory Distress Syndrome ARDS
Randomized participants N54 will receive 3 daily doses of up to 90-million cellsunit dose cumulative dose of up to 270 million UC-MSCs or blinded placebo The MSC product will be provided as 25 million cellsml suspended in PlasmaLyte A containing 5 Human Albumin The appearance-matched placebo product contains the same excipients PlasmaLyte A and 5 Human Albumin as the UC-MSCs
Randomized participants N54 will receive 3 daily doses of up to 90-million cellsunit dose cumulative dose of up to 270 million UC-MSCs or blinded placebo The MSC product will be provided as 25 million cellsml suspended in PlasmaLyte A containing 5 Human Albumin The appearance-matched placebo product contains the same excipients PlasmaLyte A and 5 Human Albumin as the UC-MSCs
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None