Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04603742
Status:
WITHDRAWN
Last Update Posted:
2022-01-25
First Post:
2020-10-21
Brief Title:
Anakinra COVID-19 Cytokine Storm
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Anakinra in Adults With Severe COVID-19 and Features of Cytokine Storm Syndrome A Randomized Double-blind Placebo-controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding did not go through
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOBI
Brief Summary:
The clinical syndrome associated with infection of the Coronavirus Disease 2019 COVID-19 is notable for its variable clinical expression Infection and transmission of the virus by asymptomatic individuals have been noted and represent one end of the clinical spectrum while multi-organ failure particularly pulmonary failure and death represent the most severe end of the clinical spectrum In a recent study published from the investigators institution about the first 393 patients with COVID-19 771 had a fever a mechanism driven by IL-1 This suggests that there may be an excess release of IL-1 present
Cytokine storm syndrome CSS has been observed in patients with COVID-19 and has been proposed to contribute to the acute pulmonary failure that occurs In distinct clinical settings macrophage activation syndrome elevated levels of pro-inflammatory cytokines including IL-1 IL-6 and others as well as elevations in laboratory indicators including ferritin CRP d-dimer and lymphopenia have been observed IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic responses including inflammatory and immunological responses Anakinra a recombinant IL-1 receptor antagonist has shown promise in treating CSS It inhibits both IL-1-alpha and IL-1-beta It is an FDA approved medication used in rheumatoid arthritis RA and Cryopyrin-Associated Periodic Syndromes CAPS Anakinras ability to inhibit both IL-1 subtypes and short half-life makes it favorable to some experts In the investigators case-series using anakinra in patients with COVID-19 showed promising in preventing the need for mechanical ventilation and mortality subsequently
This study will determine the efficacy of anakinra an interleukin IL -1 receptor blocker in reducing the need for mechanical ventilation andor 28-day mortality among patients with COVID-19 who have features of CSS and severe respiratory failure The investigators will test the hypothesis that the proportion of subjects with COVID-19 features of CSS and severe respiratory failure World Health Organization WHO category 4 or 5 alive and without having required mechanical ventilation at day 28 from randomization will be 18 higher among those that receive anakinra compared to those that receive a placebo A secondary hypothesis is that the number of subjects alive at 60-days will be higher amongst those who receive anakinra compared to those who receive a placebo
Cytokine storm syndrome CSS has been observed in patients with COVID-19 and has been proposed to contribute to the acute pulmonary failure that occurs In distinct clinical settings macrophage activation syndrome elevated levels of pro-inflammatory cytokines including IL-1 IL-6 and others as well as elevations in laboratory indicators including ferritin CRP d-dimer and lymphopenia have been observed IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic responses including inflammatory and immunological responses Anakinra a recombinant IL-1 receptor antagonist has shown promise in treating CSS It inhibits both IL-1-alpha and IL-1-beta It is an FDA approved medication used in rheumatoid arthritis RA and Cryopyrin-Associated Periodic Syndromes CAPS Anakinras ability to inhibit both IL-1 subtypes and short half-life makes it favorable to some experts In the investigators case-series using anakinra in patients with COVID-19 showed promising in preventing the need for mechanical ventilation and mortality subsequently
This study will determine the efficacy of anakinra an interleukin IL -1 receptor blocker in reducing the need for mechanical ventilation andor 28-day mortality among patients with COVID-19 who have features of CSS and severe respiratory failure The investigators will test the hypothesis that the proportion of subjects with COVID-19 features of CSS and severe respiratory failure World Health Organization WHO category 4 or 5 alive and without having required mechanical ventilation at day 28 from randomization will be 18 higher among those that receive anakinra compared to those that receive a placebo A secondary hypothesis is that the number of subjects alive at 60-days will be higher amongst those who receive anakinra compared to those who receive a placebo
Detailed Description:
None
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