
Doctors study the relationship between coronavirus and pediatric shock in children
29 April 2020
The other spheres of the Pandemic
30 April 2020The treatment is based on the delivery of three doses of plitidepsin, which blocks a protein used by the coronavirus to reproduce and infect other cells.
PharmaMar has announced the start of the 'APLICOV-PC' clinical trial with 'Aplidin' (plitidepsin) for the treatment of patients with covid-19, which has already been authorized by the Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health.
This is a multicenter, randomized, parallel, open-label study to evaluate the safety profile and efficacy of three doses of plitidepsin in patients with coronavirus who require hospital admission. Three hospitals in the Community of Madrid will participate in the study. Three cohorts of patients with three different dose levels will be included in the study, to evaluate the efficacy and safety of plitidepsin at each dose level administered in patients admitted for covid-19.
In this first stage, 27 patients will be included, to whom these three different doses will be administered. The patients' viral load will be measured before treatment and once it has finished, as well as a series of clinical evolution parameters. In the event that the results were positive in this first stage, the trial would continue with the optimal dose, after speaking with the regulator, with a larger cohort of patients.
On March 13, the company announced results of in vitro studies of plitidepsin in the human coronavirus HCoV-229E, with a multiplication and propagation mechanism very similar to SARS-CoV-2, since both use the eEF1A protein. for reproduction. The studies have been carried out at the National Center for Biotechnology of the Higher Center for Scientific Research (CNB-CSIC).
Plitidepsin acts by blocking the eEF1A protein, present in human cells, and which is used by SARS-CoV-2 to reproduce and infect other cells. Through this blockade, the reproduction of the virus inside the cell is prevented, making it unviable and its spread to the rest.