Defibrotide as Prevention and Treatment of Respiratory Distress and Cytokine Release Syndrome of Covid 19.

Summary

Protection of endothelial dysfunction by intravenous infusion of Defibrotide (Defitelio), expected to decrease inflammation and expression of adhesion molecules in the endothelium, leukocyte tissue infiltration and epithelial destruction, and to promote immune tolerance through a change in the Cytokine balance, which is decisive in preventing multiorgan failure and death in patients with SARS-CoV-2 infection with clinical status grade 4 or 5 according to the WHO classification

Timeline

Start

2020-04-08

Primary completion

2023-02-28

Completion

2023-02-28

Publications

• Jara Rubio R, Martinez-Mellado AJ, Kiwitt-Cardenas J, Clavel JG, Garcia-Perez B, Castro P, Diaz-Ricart M, Carrillo-Alcaraz A, Lopez-Bernus A, Bernal Morell E, Roura A, Marin S, Ruiz-Lopez FJ, Solana-Martinez E, Martinez-Bano D, Albacete Moreno CL, Andreu Soler E, Tellez Santoyo A, Fernandez Mendez S, Noguera Velasco JA, Cebreiros Lopez I, Parrilla A, Espuny-Miro A, Garcia-Bernal D, Blanquer M, Sanchez-Salinas A, Iniesta F, Hernandez Garcia C, Muro M, Minguela Puras A, Moreno-Docon A, Torres-Cantero AM, Munoz Garcia M, Serrano M, Iacobelli M, Carlo-Stella C, Wei LJ, Richardson PG, Moraleda JM. Phase IIB, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Intravenous Defibrotide for the Prevention and Treatment of Respiratory Distress and Cytokine Release Syndrome in COVID-19. Eur J Haematol. 2026 May 12. doi: 10.1111/ejh.70214. Online ahead of print.

Drugs

Indications