Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652115
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2020-12-01
Brief Title:
Defibrotide for the Treatment of Severe COVID-19
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia
Detailed Description:
This study is a prospective single-arm two-cohort phase 2 pilot study that will evaluate the safety and efficacy of defibrotide in clinically severe COVID-19 The defibrotide dose that is approved by the FDA for the treatment of post-HSCT VODSOS 625 mgkg IV q6 hours will be used
Cohort 1 will consist of patients with COVID-19 pneumonia confirmed by PCR and radiography who are hospitalized with an oxygen requirement either supplemental O2 or mechanical ventilation are not on therapeutic dose anticoagulation and require no more than one vasopressive agent to maintain hemodynamic stability Cohort 2 will consist of patients with COVID-19 pneumonia confirmed by PCR and radiography who are hospitalized in the ICU and are at elevated risk of hemorrhage andor hypotension the former defined as a requirement for therapeutic dose anticoagulation for active thrombosis ECMO or CRRT and the latter defined as a requirement for two vasopressive agents to maintain hemodynamic stability
In cohort 2 only a 66 dose de-escalation design will be utilized in which if 2 of 6 DLTs are experienced in the first 6 subjects the dose will be reduced from 625 mgkg IV q6hrs to 10mgkgd CIVI If there are 0 or 1 DLTs in the first 6 subjects at the FDA-approved dose another 6 subjects will be enrolled at the same dose Grade 34 hemorrhage and significant new hypotension will be considered DLTs
Cohort 1 will consist of patients with COVID-19 pneumonia confirmed by PCR and radiography who are hospitalized with an oxygen requirement either supplemental O2 or mechanical ventilation are not on therapeutic dose anticoagulation and require no more than one vasopressive agent to maintain hemodynamic stability Cohort 2 will consist of patients with COVID-19 pneumonia confirmed by PCR and radiography who are hospitalized in the ICU and are at elevated risk of hemorrhage andor hypotension the former defined as a requirement for therapeutic dose anticoagulation for active thrombosis ECMO or CRRT and the latter defined as a requirement for two vasopressive agents to maintain hemodynamic stability
In cohort 2 only a 66 dose de-escalation design will be utilized in which if 2 of 6 DLTs are experienced in the first 6 subjects the dose will be reduced from 625 mgkg IV q6hrs to 10mgkgd CIVI If there are 0 or 1 DLTs in the first 6 subjects at the FDA-approved dose another 6 subjects will be enrolled at the same dose Grade 34 hemorrhage and significant new hypotension will be considered DLTs
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