Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04901689
Status:
SUSPENDED
Last Update Posted:
2022-04-15
First Post:
2021-05-24
Brief Title:
Leronlimab in Patients With Coronavirus Disease 2019 COVID-19 With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
A Phase 3 Randomized Double Blind Placebo Controlled Trial to Evaluate the Efficacy and Safety of Leronlimab in Combination With Standard of Care for Patients With Coronavirus Disease 2019 COVID-19 With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation
Status:
SUSPENDED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pending DSMB evaluation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Leronlimab PRO 140 is a humanized IgG4k monoclonal antibody mAb that recognizes the C-C chemokine receptor type 5 CCR5 Disruption of the C-C chemokine ligand 5 CCL5-CCR5 axis via leronlimab-mediated CCR5 blockade might prevent pulmonary trafficking of pro-inflammatory leukocytes and dampen pathogenic immune activation in coronavirus disease 2019 COVID-19
The purpose of the study is to assess the safety and efficacy of leronlimab plus standard of care in critically ill patients hospitalized with COVID-19 pneumonia who are requiring mechanical ventilation or extracorporeal oxigenation ECMO
The purpose of the study is to assess the safety and efficacy of leronlimab plus standard of care in critically ill patients hospitalized with COVID-19 pneumonia who are requiring mechanical ventilation or extracorporeal oxigenation ECMO
Detailed Description:
Leronlimab PRO 140 is a humanized IgG4k monoclonal antibody mAb that recognizes the C-C chemokine receptor type 5 CCR5 CCR5 is expressed predominantly on T cells but also found on macrophages dendritic cells and eosinophils to mediate chemotaxis in response to its cognate ligands that include CCL5 RANTES CCL3 MIP-1α and CCL4 MIP-1β These ligands are integral in the recruitment of these immune cells to inflammatory sites The immunopathogenesis of COVID-19 likely involves the excessive influx of immune cells into the lung Disruption of the CCL5-CCR5 axis via leronlimab-mediated CCR5 blockade might prevent pulmonary trafficking of pro-inflammatory leukocytes and dampen pathogenic immune activation in COVID-19
The purpose of the study is to assess the safety and efficacy of leronlimab plus standard of care in critically ill patients hospitalized with COVID-19 pneumonia who are requiring mechanical ventilation or extracorporeal oxigenation ECMO
This is a Phase 3 2-arm randomized double blind placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab PRO 140 as an add on therapy to the institutional standard of care SoC for the management of critically ill patients with COVID-19 pneumonia
Patients will be randomized in a 11 ratio to receive up to four doses of 700 mg leronlimab PRO 140 or placebo Leronlimab or placebo will be administered by 30-minute intravenous IV infusion weekly over a 4-week treatment period No treatments will be administered post-discharge
The participant will be evaluated on each study day while hospitalized up until and including Day 28 The daily visits will capture clinical status - ordinal scale and the occurrence of adverse events A complete follow-up assessment will be performed at Days 7 14 21 28 42 and 60 for those who are hospitalized at these specific timepoints Follow-up visits can be conducted as telephone or video contact visits if subject is discharged from the hospital prior to the complete follow-up visits
The purpose of the study is to assess the safety and efficacy of leronlimab plus standard of care in critically ill patients hospitalized with COVID-19 pneumonia who are requiring mechanical ventilation or extracorporeal oxigenation ECMO
This is a Phase 3 2-arm randomized double blind placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab PRO 140 as an add on therapy to the institutional standard of care SoC for the management of critically ill patients with COVID-19 pneumonia
Patients will be randomized in a 11 ratio to receive up to four doses of 700 mg leronlimab PRO 140 or placebo Leronlimab or placebo will be administered by 30-minute intravenous IV infusion weekly over a 4-week treatment period No treatments will be administered post-discharge
The participant will be evaluated on each study day while hospitalized up until and including Day 28 The daily visits will capture clinical status - ordinal scale and the occurrence of adverse events A complete follow-up assessment will be performed at Days 7 14 21 28 42 and 60 for those who are hospitalized at these specific timepoints Follow-up visits can be conducted as telephone or video contact visits if subject is discharged from the hospital prior to the complete follow-up visits
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