se of Defibrotide to reduce progression of acute respiratory failure rate inpatients with COVID-19 pneumonia

Phase 1

• Conditions: Severe COVID-19 pneumonia; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10035737Term: Pneumonia viralSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001513-20-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Documented COVID-19 pneumonia: defined as upper respiratory tract swab positive for COVID-19 and/or imaging at computed tomography scan
suggestive of COVID-19 pneumonia
• SaO2 of 92% or less without oxygen support, or reduction of 3% from basal value of SaO2, or a ratio of PaO2/FiO2 below 300.
• Any gender
• Age >= 18 years
• Written informed consent or as per Ethical Committee indication in case of patients not able to express written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• Onset of COVID-19 pneumonia >14 days
• Orotracheal intubation
• Uncontrolled systemic infection (other than COVID-19)
• Concomitant use of thrombolytic therapy or systemic anticoagulant therapy
• Haemodynamic instability, defined as inability to maintain mean arterial pressure with single pressor support
• Hypersensitivity to the active substance or to any of the excipients of the experimental drug
• Patients who, based on the investigator's clinical judgement, are not able to receive the treatment
• Pregnancy or breastfeeding patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that the treatment with Defibrotide administered intravenously in addition to the best available therapy according to institutional guidelines 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;Secondary Objective: • To evaluate the safety of Defibrotide in the cohort of patients treated (incidence of adverse events)<br>• To evaluate the duration of hospitalization for patients enrolled<br>• To evaluate the overall survival at day+28 after start treatment with Defibrotide<br>• To evaluate the change in biological features of systemic inflammation (PCR, LDH, ferritin, IL-10, IL-6, TNF-alpha, IFN-gamma, PTX3) at day +7 and +14 after start of treatment with Defibrotide;Primary end point(s): Respiratory-failure rate (RFR);Timepoint(s) of evaluation of this end point: 14 days from treatment start

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Adverse event; Duration of hospitalization; Systemic inflammation; Overall survival;Timepoint(s) of evaluation of this end point: 7 days from treatment start; 14 days from treatment start; 7 days and 14 days from treatment start; 28 days from treatment start