Clinical trial NCT05121740: Extension Study in a Cohort of Adult Patients With COVID-19 Infection
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19 Infection
Keywords: Plitidepsin
COVID-19
Post-COVID morbidity
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
Collaborators: name: Apices Soluciones S.L.
First posted: 2021-11-16
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Follow up Multicentric extension study of APLICOV-PC clinical trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number and Percentage of Participants With Complications Related to Post COVID-19 Infection
timeFrame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
Secondary outcomes:
measure: Patients Requiring Oxygen Therapy
timeFrame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
measure: Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not).
timeFrame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months..
measure: Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2)
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: Forced Expiratory Volume 1 (FEV1)
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: Lung Diffusion Testing
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: Patients With Alterations in Chest Radiography
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: Patients With Electrocardiogram Alterations
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: Patients With ≥Grade 2 Alterations in Laboratory Parameters
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: FEV1/FVC
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: Forced Vital Capacity (FVC)
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: Arterial Oxygen Saturation (SaO2)
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: Barthel Index
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: Patients Requiring Hospital Readmission
timeFrame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
measure: 6 Minute Walking Test (Total Distance)
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: 6 Minute Walking Test (Expected Distance)
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: 6 Minute Walking Test (Percentage of Predicted Distance)
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
measure: 6 Minute Walking Test (Number of Laps of 60 m)
timeFrame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Boadilla del monte
country: Spain
facility: Hospital Universitario HM Montepríncipe
state: Madrid
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
Study officials:
affiliation: Hospital Universitario HM Montepríncipe
name: José Felipe Varona, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Princesa
name: Pedro Landete, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Quironsalud
name: Pablo Guisado-Vasco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Roger Paredes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varona JF, Landete P, Paredes R, Vates R, Torralba M, Guisado-Vasco P, Porras L, Munoz P, Gijon P, Ancochea J, Saiz E, Meira F, Jimeno JM, Lopez-Martin JA, Estrada V. Plitidepsin in adult patients with COVID-19 requiring hospital admission: A long-term follow-up analysis. Front Cell Infect Microbiol. 2023 Feb 22;13:1097809. doi: 10.3389/fcimb.2023.1097809. eCollection 2023.