Extension Study in a Cohort of Adult Patients With COVID-19 Infection (E-APLICOV-PC)

March 21, 2022 updated by: PharmaMar

Extension Study in a Cohort of Adult Patients With SARS-CoV-2 Infection Requiring Hospital Admission and Received Treatment With Plitidepsin in the APLICOV-PC Study

The main objective of this study is to evaluate the incidence of post-COVID morbidity and characterize the complications profile in patients who participated in the APLICOV-PC study. APLICOV-PC study was a multicenter, randomized, proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin (1,5 mg, 2,0 mg and 2,5 mg) administered three consecutive days, in adult patients with confirmed diagnosis of COVID-19 who require hospital admission.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The APLICOV-PC proof of concept study demonstrated the antiviral activity of plitidepsin in terms of reducing viral load, inducing recovery, and impact on lymphocyte reconstitution and other inflammatory parameters.

A percentage of patients, which varies between 10 and 25%, continue to show symptoms at 3 months after contracting the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: For some of them this significantly restricts their life, requiring them to take long-term sickness leave from work, and leaving them with sequelae that may continue for more than one year.

With this study, Pharmamar intends to evaluate whether the treatment with plitidepsin, by attaining a reduction in the viral load and a faster recovery of the patient, could have a relevant impact on the emergence of sequelae resulting from the SARS-CoV-2 infection.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Ciudad Real, Spain, 13005
        • Hospital General de Ciudad Real
      • Getafe, Spain, 280989
        • Hospital Universitario de Getafe
      • Guadalajara, Spain, 19002
        • Hospital Universitario de Guadalajara
      • Madrid, Spain, 28040
        • Hospital Universitario Clinico San Carlos
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 280029
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 280127
        • Hospital Universitario La Princesa
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
    • Madrid
      • Boadilla del monte, Madrid, Spain, 28660
        • Hospital Universitario HM Monteprincipe
      • Pozuelo De Alarcón, Madrid, Spain, 28223
        • Hospital Universitario Quironsalud Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient who participated in the APLICOV-PC study receiving treatment with plitidepsin and who gives consent.

Exclusion Criteria:

  • There are no exclusion criteria for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Experimental 1
In the APLICOV-PC study, patients of arm A received 1.5 mg of plitidepsin / day for 3 consecutive days (total dose 4.5 mg).
Drug: Plitidepsin 1.5 mg / day
Plitidepsin 1.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 4.5 mg).
Experimental: Arm B: Experimental 2
In the APLICOV-PC study, patients of arm B received 2.0 mg of plitidepsin / day for 3 consecutive days (total dose 6.0 mg).
Drug: Plitidepsin 2.0 mg / day
Plitidepsin 2.0 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 6.0 mg).
Experimental: Arm C: Experimental 3
In the APLICOV-PC study, patients of arm C received 2.5 mg of plitidepsin / day for 3 consecutive days (total dose 7.5 mg).
Drug: Plitidepsin 2.5 mg / day
Plitidepsin 2.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 7.5 mg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications
Time Frame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
Percentage of patients who developed complications related to COVID-19 infection
Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
Patients requiring hospital readmission
Time Frame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
Percentage of patients requiring hospital readmission
Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
Patients requiring oxygen therapy
Time Frame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
Percentage of patients requiring oxygen therapy
Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
Duration of oxygen therapy
Time Frame: From start of oxygen therapy until end of oxygen therapy, assessed up to 12 months
Duration of oxygen therapy mean, standard deviation.
From start of oxygen therapy until end of oxygen therapy, assessed up to 12 months
Patients with complications
Time Frame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months..
Percentage of patients with complications
Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months..
Barthel index
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Percentage of patients at each category according to the score obtained: 0-20: Total dependence; 21-60: Severe dependence; 61-90: Moderate dependence; 91-99: Low dependence; 100: Independence
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Arterial oxygen saturation (SaO2)
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
SaO2 mean, standard deviation.
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Ratio of partial pressure arterial oxygen (PaO2) and fraction of inspired oxygen (FiO2)
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
PaO2/FiO2 mean, standard deviation.
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Forced vital capacity (FVC)
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
FVC mean, standard deviation.
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Forced expiratory volume 1 (FEV1)
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
FEV1 mean, standard deviation.
At study inclusion, an average of 12 months after end of APLICOV-PC study.
FEV1/FVC
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
FEV1/FVC mean, standard deviation.
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Diffusion test
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Diffusion test mean, standard deviation.
At study inclusion, an average of 12 months after end of APLICOV-PC study.
6 minute walking test
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
6 minute walking test mean, standard deviation.
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Modified Medical Research Council (mMRC) Dyspnea Scale
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Percentage of patients in each category of the mMRC dyspnea scale
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Patients with alterations in chest radiography
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Percentage of patients with alterations in chest radiography
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Patients with ≥grade 2 alterations in laboratory parameters
Time Frame: At study inclusion.At study inclusion, an average of 12 months after end of APLICOV-PC study.
Percentage of patients with ≥grade 2 alterations in laboratory parameters
At study inclusion.At study inclusion, an average of 12 months after end of APLICOV-PC study.
Patients with electrocardiogram alterations
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Percentage of patients with electrocardiogram alterations
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Patients with echocardiogram / multigated acquisition scan (ECHO/MUGA) alterations
Time Frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Percentage of patients with cardiac ECHO/MUGA alterations in patients who suffered a relevant cardiac event during their participation in the APLICOV-PC study,
At study inclusion, an average of 12 months after end of APLICOV-PC study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmaMar

Collaborators

Apices Soluciones S.L.

Investigators

  • Principal Investigator: José Felipe Barona, MD, Hospital Universitario HM Monteprincipe
  • Principal Investigator: Pedro Landete, MD, Hospital Universitario La Princesa
  • Principal Investigator: Pablo Guisado-Vasco, MD, Quironsalud
  • Principal Investigator: Roger Paredes, MD, Germans Trias I Pujol Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2022

Primary Completion (Actual)

March 16, 2022

Study Completion (Actual)

March 16, 2022

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV-APL-A-003-21
  • 2021-004966-37 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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