Evaluating Defibrotide IV Treatment Safety and Feasibility in Adults with Severe COVID-19 Pneumonia

What this Trial Is About

Researchers are studying the safety and feasibility of defibrotide for treating severe COVID-19 pneumonia. This phase 2 pilot study focuses on patients hospitalized with confirmed COVID-19 pneumonia who require oxygen support, including those in intensive care at higher risk of bleeding or low blood pressure. The study aims to evaluate defibrotides safety profile and effects under these severe conditions. Participants will receive defibrotide intravenously at the FDA-approved dose of 6.25 mgkg every 6 hours. The study includes two cohorts Cohort 1 involves hospitalized patients with oxygen needs but stable blood pressure and no therapeutic anticoagulation, while Cohort 2 includes ICU patients at higher bleeding or hypotension risk who may undergo dose adjustments if safety concerns arise. Cohort 2 uses a dose de-escalation design to monitor for serious side effects. Throughout the study, participants will be regularly monitored for adverse events like bleeding and hypotension for up to 21 days. Assessments include clinical evaluations and imaging confirming lung involvement. Safety and feasibility data will guide treatment decisions. The study spans several years, with participants involved during hospitalization and follow-up periods to assess treatment impact and tolerability.

Defibrotide for the Treatment of Severe COVID-19