Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920916
Status:
COMPLETED
Last Update Posted:
2023-11-03
First Post:
2021-06-08
Brief Title:
Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Safety and Efficacy of the Treatment of Hospitalized Patients With COVID 19 Infection With an Inhibitor of IL-4 and IL-13 Signaling A Phase IIa Trial
Status:
COMPLETED
Status Verified Date:
2023-10
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:
SafeDrop
Brief Summary:
This is a randomized double-blind placebo-controlled superiority phase IIa trial to assess the safety and efficacy of dupilumab use in hospitalized patients with moderate to severe COVID-19 infection Subsequently we conducted a 1 year follow up study to investigate the occurrence of Post COVID conditions PCC in our study population through assessment of pulmonary function symptoms neurocognition and immune biomarkers to observe for any treatment group differences
Detailed Description:
A total of 40 eligible subject were enrolled and randomized in a 11 ratio to receive either dupilumab or placebo stratifying on the disease severity measured by the required oxygen 15L or 15L by nasal cannula Both arms received standard of care management per current National Institutes of Health NIH COVID-19 treatment guideline in addition to their randomized treatments Patients were then followed prospectively for up to 360 days after enrollment
As an extension to the randomized double-blind placebo-controlled trial assessing dupilumab for treatment of those hospitalized with acute moderate to severe COVID-19 subjects were followed up at 1 year for evaluation of pulmonary function testing PFT pulmonary imaging immune biomarkers neurocognition and symptoms
As an extension to the randomized double-blind placebo-controlled trial assessing dupilumab for treatment of those hospitalized with acute moderate to severe COVID-19 subjects were followed up at 1 year for evaluation of pulmonary function testing PFT pulmonary imaging immune biomarkers neurocognition and symptoms
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSR220171 | OTHER | UVA IRB | None |