Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS)
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|ClinicalTrials.gov Identifier: NCT04530604|
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : October 14, 2020
This clinical trial will enroll participants that have pneumonia caused by the COVID-19 virus. During the study patients will receive 7 to up to 14 days of defibrotide. After completing the treatment, participants will have 30 day follow-up check-up to assess for adverse events and clinical status. This final assessment can be done virtually, by telephone or electronically (email) if the patient cannot be contacted by phone. No in-person visit is required.
The hypothesis of this trial is that defibrotide therapy given to patients with severe SARS-CoV2 ARDS will be safe and associated with improved overall survival, within 28 days of therapy initiation.
|Condition or disease||Intervention/treatment||Phase|
|COVID Sars-CoV2 COVID-19 Acute Respiratory Distress Syndrome||Drug: Defibrotide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Defibrotide Therapy for SARS-CoV2 Acute Respiratory Distress Syndrome (ARDS)|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
All patients will receive 25 milligram/kilogram/day (mg/kg/day) of defibrotide, given in 4 divided doses (approximately every 6 hours), each dose infused over 2-hours intravenously (IV).
The planned duration of study therapy is 7 days (while in the hospital), with the following qualifications:
Other Name: defitelio
- Number of major hemorrhagic complications within 14 days of initiation of treatment [ Time Frame: 14 days ]
Major hemorrhagic complications will be based on the International Society on Thrombosis and Haemostasis Bleeding scale.
- Fatal Bleeding, and/or
- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome, and/or
- Bleeding associated with a decline in hemoglobin level of > 2.0 g/dl, leading to transfusion of two or more units of whole blood or red cells.
- In addition, symptomatic alveolar hemorrhage, macroscopic hematuria, uncontrolled menorrhagia or epistaxis or bleeding from any wound site would also be considered a major hemorrhagic event.
- Overall survival [ Time Frame: 28 days ]Proportion of the twelve patients who are alive at day 28 after starting treatment.
- Overall survival [ Time Frame: 14 days ]Proportion of the twelve patients who are alive at Day 14 after starting treatment.
- Ventilator free survival [ Time Frame: 14 days ]Day 14 ventilator-free survival will be summarized by the proportion of the twelve patients who are both alive and not using a ventilator at Day 14 after starting treatment.
- Number of ventilator free days within 14 days of study entry [ Time Frame: 14 days ]
- The time to improvement in oxygenation [ Time Frame: up to 14 days ]Improvement in oxygenation defined as an increase in atio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) of 50 (or greater) compared to the nadir of PaO2/FiO2.
- Mean change in the WHO COVID-19 Ordinal Scale during therapy [ Time Frame: up to 14 days ]
Ambulatory (1) - No limitation of activities (2) - Limitations of activities
Hospitalized: (3) no oxygen therapy (4) oxygen by mask or nasal prongs
Hospitalized: (5) Non-invasive ventilation or high-flow oxygen (6) Intubation and mechanical ventilation (7) Mechanical ventilation plus additional organs support-pressors, renal replacement therapy (RRT), Extracorporeal membrane oxygenation (ECMO)
Dead: (8) Death
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): NCT04530604
|Contact: Mary Maliarik, PhDfirstname.lastname@example.org|
|Contact: Gregory Yanik, MDemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Mary Maliarik, PhD 734-615-8627 firstname.lastname@example.org|
|Principal Investigator:||Gregory Yanik, MD||University of Michigan|