COVID-19 InfectionPhase 1/2E-APLICOV-PCNCT05121740
Extension Study in a Cohort of Adult Patients With COVID-19 Infection
A Phase 1/2 study testing Plitidepsin 1.5 mg / day, Plitidepsin 2.0 mg / day and Plitidepsin 2.5 mg / day in people with COVID-19 Infection, run by PharmaMar at 10 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Plitidepsin 1.5 mg / day, Plitidepsin 2.0 mg / day and Plitidepsin 2.5 mg / day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 10 sitesSpain
- Study dates
- 25 Jan 2022to 16 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who participated in the APLICOV-PC study receiving treatment with plitidepsin and who gives consent.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitario HM Montepríncipe
Boadilla del Monte, Madrid, 28660
Hospital General de Ciudad Real
Ciudad Real, 13005
Hospital Universitario de Getafe
Getafe, 280989
Hospital Universitario de Guadalajara
Guadalajara, 19002
Hospital Universitario Ramón y Cajal
Madrid, 280029
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Hospital Universitario La Princesa
Madrid, 280127
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
About this study
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
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.
Read the 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.
- Conditions
- COVID-19 Infection
- Being tested
- Plitidepsin 1.5 mg / day, Plitidepsin 2.0 mg / day, Plitidepsin 2.5 mg / day
- Keywords
- Plitidepsin, COVID-19, Post-COVID morbidity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plitidepsin 1.5 mg / dayDrug
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 / dayDrug
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 / dayDrug
Plitidepsin 2.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 7.5 mg).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Plitidepsin 1.5 mg / day |
| 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). Receives: Drug: Plitidepsin 2.0 mg / day |
| 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). Receives: Drug: Plitidepsin 2.5 mg / day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
Secondary outcomes (18)
Patients Requiring Oxygen Therapy
Percentage of patients requiring oxygen therapy
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Patients With Electrocardiogram Alterations
Percentage of patients with electrocardiogram alterations
Measured: 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.
Measured: 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;
- shortness of breath when hurrying on the level or walking up a slight hill;
- 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;
- stops for breath after walking ∼100 m or after few minutes on the level; and
- too breathless to leave the house, or breathless when dressing or undressing.
Measured: At study inclusion, an average of 12 months after end of APLICOV-PC study.
FEV1/FVC
FEV1/FVC mean, standard deviation.
Measured: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Forced Vital Capacity (FVC)
FVC mean, standard deviation.
Measured: 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
Measured: 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
Measured: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Patients Requiring Hospital Readmission
Percentage of patients requiring hospital readmission
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start25 Jan 2022
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Follow up Multicentric extension study of APLICOV-PC clinical trial.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L.
- Responsible party
- Sponsor
- Investigators
- José Felipe Varona, MD, Principal investigator, Hospital Universitario HM MontepríncipePedro Landete, MD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaPablo Guisado-Vasco, MD, Principal investigator, QuironsaludRoger Paredes, MD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121740
- Sponsor's protocol ID
- AV-APL-A-003-21
- Other IDs
- 2021-004966-37
- Acronym
- E-APLICOV-PC
- Status last verified
- Dec 2024
- First submitted
- 8 Nov 2021
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36909731
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05121740
- Acronym / sponsor ID
- E-APLICOV-PC / AV-APL-A-003-21
- Conditions
- COVID-19 Infection
- Keywords
- Plitidepsin, COVID-19, Post-COVID morbidity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L.
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Follow up Multicentric extension study of APLICOV-PC clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Experimental 1 | Experimental | Drug: Plitidepsin 1.5 mg / dayIn 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 | Drug: Plitidepsin 2.0 mg / dayIn 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 | Drug: Plitidepsin 2.5 mg / dayIn the APLICOV-PC study, patients of arm C received 2.5 mg of plitidepsin / day for 3 consecutive days (total dose 7.5 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who participated in the APLICOV-PC study receiving treatment with plitidepsin and who gives consent.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plitidepsin 1.5 mg / dayPlitidepsin 1.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 4.5 mg). | Drug | Arm A: Experimental 1 |
| Plitidepsin 2.0 mg / dayPlitidepsin 2.0 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 6.0 mg). | Drug | Arm B: Experimental 2 |
| Plitidepsin 2.5 mg / dayPlitidepsin 2.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 7.5 mg). | Drug | Arm C: Experimental 3 |
Primary outcome
Number and Percentage of Participants With 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.
Number and percentage of patients who developed complications related to post COVID-19 infection
18 secondary outcomes
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).
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)
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Forced Expiratory Volume 1 (FEV1)
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Lung Diffusion Testing
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
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
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Patients With ≥Grade 2 Alterations in Laboratory Parameters
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
FEV1/FVC
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Forced Vital Capacity (FVC)
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Arterial Oxygen Saturation (SaO2)
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Barthel Index
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
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)
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
6 Minute Walking Test (Expected Distance)
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
6 Minute Walking Test (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)
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36909731Varona 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Felipe Varona, MD principal investigator
Hospital Universitario HM Montepríncipe
Pedro Landete, MD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Pablo Guisado-Vasco, MD principal investigator
Quironsalud
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Plitidepsin 1.5 mg / day, Plitidepsin 2.0 mg / day and Plitidepsin 2.5 mg / day in people with COVID-19 Infection, run by PharmaMar at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Participants With 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05121740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.