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

COVID-19 Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05121740
• Other study ID #: AV-APL-A-003-21
• Secondary ID: 2021-004966-37
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 18, 2022
• Est. completion date: March 16, 2022

Study information

• Verified date: March 2022
• Source: PharmaMar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 16, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• COVID-19 Infection
• Infections

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Universitario HM Montepríncipe	Boadilla del monte	Madrid
Spain	Hospital General de Ciudad Real	Ciudad Real
Spain	Hospital Universitario de Getafe	Getafe
Spain	Hospital Universitario de Guadalajara	Guadalajara
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Clínico San Carlos	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
PharmaMar	Apices Soluciones S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complications	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.
Primary	Patients requiring hospital readmission	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.
Primary	Patients requiring oxygen therapy	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.
Primary	Duration of oxygen therapy	Duration of oxygen therapy mean, standard deviation.	From start of oxygen therapy until end of oxygen therapy, assessed up to 12 months
Primary	Patients with complications	Percentage of patients with complications	Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months..
Primary	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	At study inclusion, an average of 12 months after end of APLICOV-PC study.
Primary	Arterial oxygen saturation (SaO2)	SaO2 mean, standard deviation.	At study inclusion, an average of 12 months after end of APLICOV-PC study.
Primary	Ratio of partial pressure arterial oxygen (PaO2) and fraction of inspired oxygen (FiO2)	PaO2/FiO2 mean, standard deviation.	At study inclusion, an average of 12 months after end of APLICOV-PC study.
Primary	Forced vital capacity (FVC)	FVC mean, standard deviation.	At study inclusion, an average of 12 months after end of APLICOV-PC study.
Primary	Forced expiratory volume 1 (FEV1)	FEV1 mean, standard deviation.	At study inclusion, an average of 12 months after end of APLICOV-PC study.
Primary	FEV1/FVC	FEV1/FVC mean, standard deviation.	At study inclusion, an average of 12 months after end of APLICOV-PC study.
Primary	Diffusion test	Diffusion test mean, standard deviation.	At study inclusion, an average of 12 months after end of APLICOV-PC study.
Primary	6 minute walking test	6 minute walking test mean, standard deviation.	At study inclusion, an average of 12 months after end of APLICOV-PC study.
Primary	Modified Medical Research Council (mMRC) Dyspnea Scale	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.
Primary	Patients with alterations in chest radiography	Percentage of patients with alterations in chest radiography	At study inclusion, an average of 12 months after end of APLICOV-PC study.
Primary	Patients with =grade 2 alterations in laboratory parameters	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.
Primary	Patients with electrocardiogram alterations	Percentage of patients with electrocardiogram alterations	At study inclusion, an average of 12 months after end of APLICOV-PC study.
Primary	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,	At study inclusion, an average of 12 months after end of APLICOV-PC study.