APLICOV-Pc1,2 represents a proof of the concept clinical trial with plitidepsin, for the treatment of patients with COVID-19 that require hospital admission.
This is a multicenter, randomized, parallel, open-label study to assess the safety profile, efficacy with three different plitidepsin dose level cohorts (1.5mg – 2.0mg – 2.5mg), administered over three consecutive days, in patients with COVID-19, who required hospital admission.
The patients’ viral load was evaluated quantitatively, at the same center, at the beginning of the treatment and on days 4, 7, 15 and 30. The study has demonstrated a substantial reduction of the viral load in patients between days 4 and 7 from starting the treatment, the average reduction of the viral load on day 7 was 50% and on day 15, 70%. More than 90% of the patients included in the trial had medium or high viral loads on beginning the treatment.
With these data, , the Company has obtained the authorization for an extension of the patient cohort. This extension will help to obtain more data on the treatment of this indication. Moreover, the Company will begin, in the next few days, conversations with the regulatory agencies to define the next phase III pivotal study for plitidepsin in patients with COVID-19, who require hospitalization.
- Spanish Clinical Trials Registry: 2020-001993-31: reec.aemps.es/reec/estudio/2020-001993-31
- ClinicalTrials.gov: NCT04382066: https://clinicaltrials.gov/ct2/show/NCT04382066?term=plitidepsin&draw=2&rank=8