Status:
COMPLETED
Defibrotide in COVID-19 Pneumonia
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Patients With COVID-19 Pneumonia Will Allow to Detect an Absolute Reduction in the Rate of Respiratory-failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Institut...
Detailed Description
As of March 12, 2020, coronavirus disease 2019 (COVID-19) has been confirmed in 125 048 people worldwide, carrying a mortality of approximately 3·7%, 1 compared with a mortality rate of less than 1% f...
Eligibility Criteria
Inclusion
- Documented COVID-19 pneumonia: defined as upper respiratory tract specimen (nasopharyngeal swab (NPS) or viral throat swab) positive for COVID-19 and/or imaging at computed tomography scan suggestive of COVID-19 pneumonia
- Oxygen saturation (SaO2) of 92% or less without oxygen support, or reduction of 3% from basal value of SaO2, or a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) (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
Exclusion
- Onset of COVID-19 pneumonia \>14 days
- Orotracheal intubation
- Uncontrolled systemic infection (other than COVID-19)
- Concomitant use of thrombolytic therapy Concomitant systemic anticoagulant therapy (e.g. heparin, warfarin, direct thrombin inhibitors and direct factor Xa inhibitors)
- 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
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04335201
Start Date
May 20 2020
End Date
May 28 2021
Last Update
July 19 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale San Raffaele
Milan, Lombardy, Italy, 20132