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

Primary Purpose

COVID-19 Infection

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Plitidepsin 1.5 mg / day
Plitidepsin 2.0 mg / day
Plitidepsin 2.5 mg / day
Sponsored by
PharmaMar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Infection focused on measuring Plitidepsin, COVID-19, Post-COVID morbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario HM Montepríncipe
  • Hospital Universitario Quironsalud Madrid
  • Hospital General de Ciudad Real
  • Hospital Universitario de Getafe
  • Hospital Universitario de Guadalajara
  • Hospital Universitario Ramón y Cajal
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario La Princesa
  • Hospital Universitario Clínico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A: Experimental 1

Arm B: Experimental 2

Arm C: Experimental 3

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

Incidence of complications
Percentage of patients who developed complications related to COVID-19 infection
Patients requiring hospital readmission
Percentage of patients requiring hospital readmission
Patients requiring oxygen therapy
Percentage of patients requiring oxygen therapy
Duration of oxygen therapy
Duration of oxygen therapy mean, standard deviation.
Patients with complications
Percentage of patients with complications
Barthel index
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
Arterial oxygen saturation (SaO2)
SaO2 mean, standard deviation.
Ratio of partial pressure arterial oxygen (PaO2) and fraction of inspired oxygen (FiO2)
PaO2/FiO2 mean, standard deviation.
Forced vital capacity (FVC)
FVC mean, standard deviation.
Forced expiratory volume 1 (FEV1)
FEV1 mean, standard deviation.
FEV1/FVC
FEV1/FVC mean, standard deviation.
Diffusion test
Diffusion test mean, standard deviation.
6 minute walking test
6 minute walking test mean, standard deviation.
Modified Medical Research Council (mMRC) Dyspnea Scale
Percentage of patients in each category of the mMRC dyspnea scale
Patients with alterations in chest radiography
Percentage of patients with alterations in chest radiography
Patients with ≥grade 2 alterations in laboratory parameters
Percentage of patients with ≥grade 2 alterations in laboratory parameters
Patients with electrocardiogram alterations
Percentage of patients with electrocardiogram alterations
Patients with echocardiogram / multigated acquisition scan (ECHO/MUGA) alterations
Percentage of patients with cardiac ECHO/MUGA alterations in patients who suffered a relevant cardiac event during their participation in the APLICOV-PC study,

Secondary Outcome Measures

Full Information

First Posted
November 8, 2021
Last Updated
March 21, 2022
Sponsor
PharmaMar
Collaborators
Apices Soluciones S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT05121740
Brief Title
Extension Study in a Cohort of Adult Patients With COVID-19 Infection
Acronym
E-APLICOV-PC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaMar
Collaborators
Apices Soluciones S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infection
Keywords
Plitidepsin, COVID-19, Post-COVID morbidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Follow up Multicentric extension study of APLICOV-PC clinical trial.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Experimental 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Arm B: Experimental 2
Arm Type
Experimental
Arm Description
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).
Arm Title
Arm C: Experimental 3
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Plitidepsin 1.5 mg / day
Intervention Description
Plitidepsin 1.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 4.5 mg).
Intervention Type
Drug
Intervention Name(s)
Plitidepsin 2.0 mg / day
Intervention Description
Plitidepsin 2.0 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 6.0 mg).
Intervention Type
Drug
Intervention Name(s)
Plitidepsin 2.5 mg / day
Intervention Description
Plitidepsin 2.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 7.5 mg).
Primary Outcome Measure Information:
Title
Incidence of complications
Description
Percentage of patients who developed complications related to COVID-19 infection
Time Frame
Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
Title
Patients requiring hospital readmission
Description
Percentage of 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.
Title
Patients requiring oxygen therapy
Description
Percentage of 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.
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy mean, standard deviation.
Time Frame
From start of oxygen therapy until end of oxygen therapy, assessed up to 12 months
Title
Patients with complications
Description
Percentage of patients with complications
Time Frame
Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months..
Title
Barthel index
Description
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
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Title
Arterial oxygen saturation (SaO2)
Description
SaO2 mean, standard deviation.
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Title
Ratio of partial pressure arterial oxygen (PaO2) and fraction of inspired oxygen (FiO2)
Description
PaO2/FiO2 mean, standard deviation.
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Title
Forced vital capacity (FVC)
Description
FVC mean, standard deviation.
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Title
Forced expiratory volume 1 (FEV1)
Description
FEV1 mean, standard deviation.
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Title
FEV1/FVC
Description
FEV1/FVC mean, standard deviation.
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Title
Diffusion test
Description
Diffusion test mean, standard deviation.
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Title
6 minute walking test
Description
6 minute walking test mean, standard deviation.
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Title
Modified Medical Research Council (mMRC) Dyspnea Scale
Description
Percentage of patients in each category of the mMRC dyspnea scale
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Title
Patients with alterations in chest radiography
Description
Percentage of patients with alterations in chest radiography
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Title
Patients with ≥grade 2 alterations in laboratory parameters
Description
Percentage of 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.
Title
Patients with electrocardiogram alterations
Description
Percentage of patients with electrocardiogram alterations
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.
Title
Patients with echocardiogram / multigated acquisition scan (ECHO/MUGA) alterations
Description
Percentage of patients with cardiac ECHO/MUGA alterations in patients who suffered a relevant cardiac event during their participation in the APLICOV-PC study,
Time Frame
At study inclusion, an average of 12 months after end of APLICOV-PC study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Felipe Barona, MD
Organizational Affiliation
Hospital Universitario HM Montepríncipe
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro Landete, MD
Organizational Affiliation
Hospital Universitario La Princesa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pablo Guisado-Vasco, MD
Organizational Affiliation
Quironsalud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roger Paredes, MD
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario HM Montepríncipe
City
Boadilla del monte
State/Province
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital General de Ciudad Real
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Getafe
ZIP/Postal Code
280989
Country
Spain
Facility Name
Hospital Universitario de Guadalajara
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
280029
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
280127
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Extension Study in a Cohort of Adult Patients With COVID-19 Infection

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