The United Kingdom was the first country to give the green light to authorize English patients to enter the NEPTUNE phase III clinical trial with Aplidin (plitidepsin) for the treatment of hospitalized patients with moderate infection of covid-19.
The trial plans to recruit more than 600 patients, in around 70 centers in the UK, other European countries and the rest of the world. In Spain, sources from PharmaMar pointed out, in process of evaluation by the Spanish Medicines Agency.
The study will compare this drug with two dose levels (1.5 or 2.5 mg) against the conventional treatment authorized in each country. The primary objective will be the percentage of patients who achieve a full recovery on day 8, and that they do not re-enter due to covid-19 infection after 31 days.
Plitidepsin works by blocking the protein eEF1A, present in human cells, and which is used by SARS-CoV-2 to reproduce and infect other cells. By means of this blockade, the reproduction of the virus within the cell is prevented, making it unviable and its spread to other cells.