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A Phase II, multicenter, randomized clinical trial of plitidepsin for the treatment of patients with COVID-19 pneumonia.

Trial Profile

A Phase II, multicenter, randomized clinical trial of plitidepsin for the treatment of patients with COVID-19 pneumonia.

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 06 Apr 2020

At a glance

  • Drugs Plitidepsin (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms APLICOV
  • Sponsors PharmaMar
  • Most Recent Events

    • 06 Apr 2020 New trial record
    • 02 Apr 2020 According to a PharmaMar media release, March 24th the APLICOV clinical trial protocol for Aplidin(plitidepsin) was submitted to the Spanish Medicines and Healthcare Products Agency (AEMPS).

Trial Overview

Purpose

A Phase II, multicenter, randomized clinical trial of plitidepsin for the treatment of patients with COVID-19 pneumonia.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 160

  • Sex male & female

Patient Inclusion Criteria

Patients with COVID-19 pneumonia

Trial Details

Organisations

  • Sponsors PharmaMar
  • Affiliations PharmaMar

Trial Dates

Other Details

  • Design multicentre; prospective; randomised
  • Phase of Trial Phase II
  • Location Spain
  • Focus Adverse reactions; Therapeutic Use

Interventions

Drugs Route Formulation
PlitidepsinPrimary Drug Intravenous Infusion

Plitidepsin

Trial Centres

Centres

Centre Name Location Trial Centre Country
PharmaMar
-
-

Trial History

Event Date Event Type Comment
06 Apr 2020 New trial record New trial record Updated 06 Apr 2020
02 Apr 2020 Other trial event According to a PharmaMar media release, March 24th the APLICOV clinical trial protocol for Aplidin(plitidepsin) was submitted to the Spanish Medicines and Healthcare Products Agency (AEMPS). Updated 06 Apr 2020

References

  1. PharmaMar. PharmaMar has submitted a Phase II clinical trial of Aplidin(R) (plitidepsin) for the treatment of COVID-19 to the Spanish Medicines Agency. Media-Rel 2020;.

    Media Release
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