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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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 infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 6.0 mg).
Plitidepsin 2.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 7.5 mg).
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario HM Montepríncipe
Boadilla del Monte, Madrid, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Number and Percentage of Participants With Complications Related to Post COVID-19 Infection
Number and percentage of patients who developed complications related to post COVID-19 infection
Time frame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
Patients Requiring Oxygen Therapy
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.
Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not).
Percentage of patients with complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not).
Time frame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months..
Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2)
PaO2/FiO2 (Ratio of partial pressure arterial oxygen and fraction of inspired oxygen) mean, standard deviation. PaO2/FiO2 ratio to evaluate disease severity and discriminate between 'Moderate' and 'Severe' categories according to FDA guidance.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Forced Expiratory Volume 1 (FEV1)
FEV1 (Forced expiratory volume 1) mean, standard deviation.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Lung Diffusion Testing
Lung difussion testing: mean and standard deviation. Unit of measure: % reference theoretical value
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Hospital General de Ciudad Real
Ciudad Real, Spain
Hospital Universitario de Getafe
Getafe, Spain
Hospital Universitario de Guadalajara
Guadalajara, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario La Princesa
Madrid, Spain
Hospital Universitario Clínico San Carlos
Madrid, Spain
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Patients With Alterations in Chest Radiography
Percentage of patients with alterations in chest radiography
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Patients With Electrocardiogram Alterations
Percentage of patients with electrocardiogram alterations
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Patients With ≥Grade 2 Alterations in Laboratory Parameters
Percentage of patients with ≥grade 2 alterations in laboratory parameters Grade measured according to NCI-CTCAE v5.0 (National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0) where Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL\* Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Modified Medical Research Council (mMRC) Dyspnea Scale
Percentage of patients in each category of the Modified Medical Research Council (mMRC) dyspnea scale. The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1. shortness of breath when hurrying on the level or walking up a slight hill; 2. walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3. stops for breath after walking ∼100 m or after few minutes on the level; and 4. too breathless to leave the house, or breathless when dressing or undressing.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
FEV1/FVC
FEV1/FVC mean, standard deviation.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Forced Vital Capacity (FVC)
FVC mean, standard deviation.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Arterial Oxygen Saturation (SaO2)
SaO2 (Arterial oxygen saturation) mean, standard deviation. Unit of measure: percentage of oxygen saturation
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Barthel Index
The Barthel index measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. 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.
Patients Requiring Hospital Readmission
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.
6 Minute Walking Test (Total Distance)
minute walking test mean, standard deviation. Total distance measured in meters (m)
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
6 Minute Walking Test (Expected Distance)
minute walking test mean, standard deviation. Expected distance (the predicted distance that a patient could walk) measured in meters (m)
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
6 Minute Walking Test (Percentage of Predicted Distance)
6 minute walking test mean, standard deviation. Unit of measure: Percentage of predicted distance
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
6 Minute Walking Test (Number of Laps of 60 m)
6 minute walking test mean, standard deviation. Unit of measure: Number of laps of 60 m
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.