Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
Study NCT ID:
NCT04477668
Status:
COMPLETED
Last Update Posted:
2022-09-09
First Post:
2020-07-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Helmet Non-Invasive Ventilation for COVID-19 Patients
Sponsor:
King Abdullah International Medical Research Center
Organization:
Study Overview
Official Title:
Helmet Non-Invasive Ventilation for COVID-19 Patients
Status:
COMPLETED
Status Verified Date:
2022-09
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:
Helmet-COVID
Brief Summary:
Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce 28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia and acute hypoxemic respiratory failure
Detailed Description:
This will be a pragmatic parallel randomized control trial that will compare helmet nonivasive ventilation with standard of care to standard of care alone in 1:1 ratio. The trial will be implemented in multiple centers.
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?: