Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04707664
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2021-01-11
Brief Title:
Sargramostim Use in COVID-19 to Recover Patient Health
Sponsor:
Partner Therapeutics Inc
Organization:
Partner Therapeutics Inc
Study Overview
Official Title:
A Randomized Phase 2b Trial Evaluating Clinical Outcomes of Inhaled Sargramostim in High-risk Patients With Mild-moderate COVID-19
Status:
COMPLETED
Status Verified Date:
2022-12
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:
SCOPE
Brief Summary:
The purpose of this research is to understand if the study drug also called sargramostim or Leukine can help prevent the worsening of COVID-19 when the study drug is inhaled This study will also help researchers understand if inhaled sargramostim can help prevent visits to the emergency room or hospitalization or death
Detailed Description:
This Phase 2b multicenter placebo-controlled double-blind study will randomize approximately 500 adult patients who are symptomatic with mild or moderate COVID-19 as defined in the FDA Guidance Document Covid-19 Developing Drugs and Biological Products for Treatment or Prevention May 2020 who are at high risk for progression to more severe disease Patients will be randomized in a 11 ratio to inhaled sargramostim plus standard of care SOC or placebo plus SOC Enrollment of patients who have completed a COVID-19 vaccination regimen or participated in a COVID-19 vaccine clinical trial will be capped at approximately 100 patients All patients will be randomized to receive either 250 mcg of sargramostim or equivalent volume of placebo diluent Treatment will be administered once daily for 5 days delivered via a vibrating mesh nebulizer Patients will be followed for up to 60 days after start of treatment
Sargramostim Leukine is a formulation of Granulocyte Macrophage Colony Stimulating Factor GM-CSF which is a critical cytokine for healthy pulmonary function Detailed studies have shown that GM-CSF is necessary for alveolar macrophage AM maturation and maintenance Although GM-CSF was discovered as a myelopoietic growth factor it has diverse additional effects that both promote differentiation of myeloid precursors into neutrophils monocytes and dendritic cells and control function of mature myeloid cells GM-CSF is also known to reverse immunoparalysis seen in sepsis resulting in beneficial outcomes In addition GM-CSF prevents bacteremia in post influenza bacterial pneumonia through locally mediated improved lung antibacterial resistance and increased reactive oxygen species production by AMs Pulmonary delivery of this GM-CSF has potential to reduce morbidity and mortality due to viral pneumonias potentially including COVID-19
Sargramostim Leukine is a formulation of Granulocyte Macrophage Colony Stimulating Factor GM-CSF which is a critical cytokine for healthy pulmonary function Detailed studies have shown that GM-CSF is necessary for alveolar macrophage AM maturation and maintenance Although GM-CSF was discovered as a myelopoietic growth factor it has diverse additional effects that both promote differentiation of myeloid precursors into neutrophils monocytes and dendritic cells and control function of mature myeloid cells GM-CSF is also known to reverse immunoparalysis seen in sepsis resulting in beneficial outcomes In addition GM-CSF prevents bacteremia in post influenza bacterial pneumonia through locally mediated improved lung antibacterial resistance and increased reactive oxygen species production by AMs Pulmonary delivery of this GM-CSF has potential to reduce morbidity and mortality due to viral pneumonias potentially including COVID-19
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