A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19 (DF in COVID19)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04652115|
Recruitment Status : Not yet recruiting
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Defibrotide||Phase 2|
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 VOD/SOS (6.25 mg/kg 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 and/or 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 6+6 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 6.25 mg/kg IV q6hrs to 10mg/kg/d 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 3/4 hemorrhage and significant new hypotension will be considered DLT's.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, single arm, two cohort clinical trial.|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19|
|Estimated Study Start Date :||January 1, 2021|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||November 1, 2023|
Deibrotide via IV
- The rate of adverse event of special interest (bleeding and hypotension) [ Time Frame: Up to 21 days ]The rate of adverse event of special interest (bleeding and hypotension)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652115
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02214|
|Contact: Paul G Richardson, MD Paul_Richardson@dfci.harvard.edu|
|Principal Investigator: Paul G Richardson, MD|