Defibrotide in COVID-19 Pneumonia (DEFI-VID19)
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|ClinicalTrials.gov Identifier: NCT04335201|
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Phase II, prospective, interventional, single-arm, multicentric, open label trial, with a parallel retrospective collection of data on not treated patients from IRCCS, San Raffaele Scientific Institute included in the institutional observational study.
A sample of 50 patients with COVID-19 pneumonia will allow to detect an absolute reduction in the rate of Respiratory-failure at day+14 after treatment of 20%, assuming that the actual rate of failure in the corresponding not treated patients is 70% (alpha=5%, power=90%, two-sided test). The software PASS15 was used for calculations.
The study will also include a parallel retrospective group of temporally concomitant patients from IRCCS, San Raffaele Scientific Institute, who did not receive an experimental treatment and who are enrolled in an already IRB approved observational study
|Condition or disease||Intervention/treatment||Phase|
|Patients With COVID-19 Pneumonia Will Allow to Detect an Absolute Reduction in the Rate of Respiratory-failure||Drug: Defibrotide Injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||prospective, interventional, single-arm, multicentric, open label trial with a parallel retrospective collection of data on not treated patients from IRCCS, San Raffaele Scientific Institute institutional observational study (ClinicalTrials.gov Identifier: NCT04318366)|
|Masking:||None (Open Label)|
|Masking Description:||Italian Hospital|
|Official Title:||Use of Defibrotide to Reduce Progression of Acute Respiratory Failure Rate in Patients With COVID-19 Pneumonia|
|Estimated Study Start Date :||April 6, 2020|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Arm Label
with the experimental drug: Defibrotide 25 mg/kg body weight total dose in 2 hours duration infusion each, every 6 hours (Defibrotide 6.25 mg/kg body weight each dose) Treatment duration = 7 days
Drug: Defibrotide Injection
Patients will be treated according to the standard institutional procedures and will receive the best available treatment as per institutional guidelines in association with the experimental drug: Defibrotide 25 mg/kg body weight total dose in 2 hours duration infusion each, every 6 hours (Defibrotide 6.25 mg/kg body weight each dose) Treatment duration = 7 days
- to able to reduce the progression of acute respiratory failure [ Time Frame: 14 days ]
To demonstrate that the treatment with Defibrotide administered intravenously in addition to the best available therapy according to institutional guidelines (protease inhibitors antiviral treatment and hydroxychloroquine (HCQ), and if needed, metilprednisolone is able to reduce the progression of acute respiratory failure, the need of mechanical ventilation, the transfer to the intensive care unit or death, in patients with severe COVID-19 pneumonia.
Patients with a baseline PaO2/FiO2 >= 200: progression of respiratory failure is defined by:
- severe gas transfer deficit (PaO2/FiO2 < 200);
- persistent respiratory distress while receiving oxygen (persistent marked dyspnea, use of accessory respiratory muscles, paradoxical respiratory movements);
- transfer to the intensive care unit;
- death. The rate will be calculated as the proportion of patients who experienced at least one of the events above by day+14 from treatment start.
- Adverse events [ Time Frame: 7 days ]To evaluate the safety of Defibrotide will be analyzed the frequency and incidence of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
- duration of hospitalization [ Time Frame: 14 days ]evaluate the time of hospitalization that will determine how much and how the administration of defibrotide can resolve the infection
- systemic inflammation [ Time Frame: 14 days ]
To evaluate the level of PCR, LDH, ferritin, IL-10, IL-6, TNF-alpha, IFN-gamma, PTX3 at day +7 and +14 after start of treatment with Defibrotide.
performed per day. Laboratory values performed at day 7 and 14 will be analyzed and compared with each other to understand their progress.
- overall survival [ Time Frame: 28 days ]To evaluate the overall survival at day+28 after start treatment with Defibrotide
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): NCT04335201
|Contact: Fabio Ciceri, MD||+39 02 2643 ext email@example.com|
|Contact: Stefania Trinca||+39 02 2643 ext firstname.lastname@example.org ; email@example.com|