Defibrotide in COVID-19 Pneumonia

• Status: Recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Treatments: Defibrotide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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