DEFCOVID
Research type
Research Study
Full title
A PHASE IIb, PROSPECTIVE, MULTICENTRE, SINGLE ARM, OPEN LABEL CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF DEFIBROTIDE IN PATIENTS WITH SEVERE COVID-19
IRAS ID
1004899
Contact name
Varun Mehra
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Eudract number
2021-006645-35
Research summary
COVID-19 is an infectious disease caused by the RNA betacoronavirus SARS-CoV-2.
Infection by the SARS-CoV-2 virus can cause acute respiratory distress syndrome; an acute severe lung condition
where organs have inadequate oxygen supply due to fluid buildup in the lungs.
The associated inflammation caused by the SARS-CoV-2 virus damages the alveolar epithelium and the capillary endothelium, causing endotheliitis, activation of coagulation, cytokine release, raised D-dimer levels and microthrombotic and ischaemic phenomena and can play a major role in multiple organ failure and death.
Many of the therapeutic options have failed to show benefit in national platform studies, while others (dexamethasone, remdesivir) have demonstrated only marginal benefit especially in patients with moderate disease severity. Even so, the morbidity and mortality of COVID-19 remains unacceptably high in severely affected patients, and so there is an urgent need to identify an effective treatment.
Previous studies with Defibrotide have shown that it has antithrombotic, endothelial vasculo-protective, antiinflammatory and immune dysfunction–modulating properties, which are critical to the course of the very severe complications seen during COVID-19 infection.
This clinical trial will study both the safety and the efficacy of Defibrotide infusion in patients who are severely affected by the SARS-CoV-2. virus.REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0262
Date of REC Opinion
4 Jul 2022
REC opinion
Further Information Favourable Opinion