Ignite Creation Date:
2024-05-06 @ 2:40 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04382066
Status:
COMPLETED
Last Update Posted:
2022-08-23
First Post:
2020-05-07
Brief Title:
Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19
Sponsor:
PharmaMar
Organization:
PharmaMar
Study Overview
Official Title:
Multicenter Randomized Parallel and Proof of Concept Study to Evaluate the Safety Profile of Three Doses of Plitidepsin in Patients With COVID-19 Requiring Hospitalization
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APLICOV-PC
Brief Summary:
In December 2019 Wuhan in Hubei province China became the center of an outbreak of pneumonia of unknown cause In a short time Chinese scientists had shared the genome information of a novel coronavirus SARS-CoV-2 from these pneumonia patients and developed a real-time reverse transcription PCR real-time RT-PCR diagnostic assay
Given no specific antiviral therapy for COVID-19 and the ready availability of plitidepsin as a potential antiviral agent based on pre-clinical studies this randomized parallel and proof of concept trial will evaluate the safety of three doses of plitidepsin in patients hospitalized with COVID-19
Given no specific antiviral therapy for COVID-19 and the ready availability of plitidepsin as a potential antiviral agent based on pre-clinical studies this randomized parallel and proof of concept trial will evaluate the safety of three doses of plitidepsin in patients hospitalized with COVID-19
Detailed Description:
In December 2019 a new infectious respiratory disease emerged in Wuhan China The agent that caused this pneumonia was identified as a new virus in the Coronaviridae family SARS-CoV-2 and the clinical symptomatology associated with the virus has been named COVID-19 COVID-19 is currently a public health emergency
Plitidepsin is an authorized drug in Australia for the treatment of multiple myeloma Antiviral activity of plitidepsin has been analyzed in a human hepatoma cell line infected with the HCoV-229E-GFP virus a virus similar to the SARS-CoV-2 virus
Taking into account that the available safety data from plitidepsin comes from patients with solid tumors that received treatment with a regimen of administration of plitidepsin for 5 consecutive days we propose a multicenter randomized proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin administered three consecutive days in adult patients with confirmed diagnosis of COVID-19 who require hospital admission
This study aims to assess safety and toxicity profile and also preliminary efficacy of plitidepsin at each dose level administered according to the proposed administration scheme in patients with COVID-19 who require hospital admission Main objective is to select the recommended dose levels of plitidepsin for a future phase II III efficacy study
Plitidepsin is an authorized drug in Australia for the treatment of multiple myeloma Antiviral activity of plitidepsin has been analyzed in a human hepatoma cell line infected with the HCoV-229E-GFP virus a virus similar to the SARS-CoV-2 virus
Taking into account that the available safety data from plitidepsin comes from patients with solid tumors that received treatment with a regimen of administration of plitidepsin for 5 consecutive days we propose a multicenter randomized proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin administered three consecutive days in adult patients with confirmed diagnosis of COVID-19 who require hospital admission
This study aims to assess safety and toxicity profile and also preliminary efficacy of plitidepsin at each dose level administered according to the proposed administration scheme in patients with COVID-19 who require hospital admission Main objective is to select the recommended dose levels of plitidepsin for a future phase II III efficacy study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001993-31 | EUDRACT_NUMBER | None | None |