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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004966-37 | EudraCT Number |
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| Name | Class |
|---|---|
| Apices Soluciones S.L. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Experimental 1 | Experimental | 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 B: Experimental 2 | Experimental | 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 C: Experimental 3 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plitidepsin 1.5 mg / day | Drug | Plitidepsin 1.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 4.5 mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Felipe Varona, MD | Hospital Universitario HM Montepríncipe | 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital Universitario HM Montepríncipe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36909731 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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All patients who participated in and received plitidepsin in the APLICOV-PC study are eligible candidates for participating in this extension study.
Patients were included in the study between 25th January 2022 and 28th February 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Experimental 1 | 1.5 mg of plitidepsin / day |
| FG001 | Arm B: Experimental 2 | 2.0 mg of plitidepsin / day |
| FG002 | Arm C: Experimental 3 | 2.5 mg of plitidepsin / day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Experimental 1 | 1.5 mg of plitidepsin / day |
| BG001 | Arm B: Experimental 2 | 2.0 mg of plitidepsin / day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months. |
|
From the informed consent signature to the end of study, approximately 1 month
No adverse events were reported during study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Experimental 1 | 1.5 mg of plitidepsin / day | 0 |
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Low sample size and a lack of control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Virology Business Unit PharmaMar | PharmaMar, S.A. | 91 846 60 00 | virologytrials@pharmamar.com; clinicaltrials@pharmamar.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2021 | Mar 8, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2022 | Mar 8, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C098980 | plitidepsin |
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Follow up Multicentric extension study of APLICOV-PC clinical trial.
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| Plitidepsin 2.0 mg / day | Drug | 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 | Drug | Plitidepsin 2.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 7.5 mg). |
|
Percentage of patients with complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). |
| 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. | 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. | 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 | 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 | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
| Patients With Electrocardiogram Alterations | Percentage of patients with electrocardiogram alterations | 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. | 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;
| At study inclusion, an average of 12 months after end of APLICOV-PC study. |
| FEV1/FVC | FEV1/FVC mean, standard deviation. | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
| Forced Vital Capacity (FVC) | FVC mean, standard deviation. | 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 | 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 | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
| 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. |
| 6 Minute Walking Test (Total Distance) | minute walking test mean, standard deviation. Total distance measured in meters (m) | 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) | 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 | 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 | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
| Boadilla del Monte |
| Madrid |
| 28660 |
| Spain |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital General de Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Universitario de Getafe | Getafe | 280989 | Spain |
| Hospital Universitario de Guadalajara | Guadalajara | 19002 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 280029 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28009 | Spain |
| Hospital Universitario La Princesa | Madrid | 280127 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| BG002 |
| Arm C: Experimental 3 |
2.5 mg of plitidepsin / day |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Median | Full Range | Kg |
|
| Height | Median | Full Range | cm |
|
| Body Surface Area | Median | Full Range | m^2 |
|
2.5 mg of plitidepsin / day |
| OG003 | Total |
|
|
| Secondary | Patients Requiring Oxygen Therapy | Percentage of patients requiring oxygen therapy | Posted | Count of Participants | Participants | Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months. |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Ratio | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | Forced Expiratory Volume 1 (FEV1) | FEV1 (Forced expiratory volume 1) mean, standard deviation. | Posted | Mean | Standard Deviation | ml | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | Lung Diffusion Testing | Lung difussion testing: mean and standard deviation. Unit of measure: % reference theoretical value | Posted | Mean | Standard Deviation | Percentage reference theoretical value | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | Patients With Alterations in Chest Radiography | Percentage of patients with alterations in chest radiography | Posted | Count of Participants | Participants | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | Patients With Electrocardiogram Alterations | Percentage of patients with electrocardiogram alterations | Posted | Count of Participants | Participants | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | 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;
| Posted | Count of Participants | Participants | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | FEV1/FVC | FEV1/FVC mean, standard deviation. | Posted | Mean | Standard Deviation | Ratio | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | Forced Vital Capacity (FVC) | FVC mean, standard deviation. | Posted | Mean | Standard Deviation | ml | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | Arterial Oxygen Saturation (SaO2) | SaO2 (Arterial oxygen saturation) mean, standard deviation. Unit of measure: percentage of oxygen saturation | Posted | Mean | Standard Deviation | Percentage of oxygen saturation | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | Patients Requiring Hospital Readmission | Percentage of patients requiring hospital readmission | Posted | Count of Participants | Participants | Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months. |
|
|
|
| Secondary | 6 Minute Walking Test (Total Distance) | minute walking test mean, standard deviation. Total distance measured in meters (m) | Posted | Mean | Standard Deviation | m | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | m | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | 6 Minute Walking Test (Percentage of Predicted Distance) | 6 minute walking test mean, standard deviation. Unit of measure: Percentage of predicted distance | Posted | Mean | Standard Deviation | Percentage of predicted distance | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Number of laps of 60 m | At study inclusion, an average of 12 months after end of APLICOV-PC study. |
|
|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Arm B: Experimental 2 | 2.0 mg of plitidepsin / day f | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Arm C: Experimental 3 | 2.5 mg of plitidepsin / day | 0 | 11 | 0 | 11 | 0 | 11 |
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Regardless relationship, i.e. related to COVID-19 infection or not. |
|
| 1 |
|
| 2 |
|
| 3 |
|
| Total dependence |
|
| Severe dependence |
|
| Moderate dependence |
|
| Low dependence |
|
| Independence |
|
| COVID-19 |
|
| No COVID-19 related |
|
| No readmission |
|