COVID-19Phase 1APLICOV-PCNCT04382066
Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19
A Phase 1 study testing Plitidepsin 1.5 mg/day, Plitidepsin 2.0 mg/day and Plitidepsin 2.5 mg/day in people with COVID-19, run by PharmaMar at 13 sites in Spain.
Trial summary
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Plitidepsin 1.5 mg/day, Plitidepsin 2.0 mg/day and Plitidepsin 2.5 mg/day
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 13 sitesSpain
- Study dates
- 12 May 2020to 26 Nov 2020
- Phase
- Phase 1
- 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 agrees to participate in the study by signing the informed consent.
- Men and women (non-pregnant) aged ≥18 years.
- COVID-19 infection confirmed by PCR obtained from nasopharyngeal exudate or sample from the lower respiratory tract.
- Patients who require hospitalization for COVID-19.
- Symptom onset at most within 10 days prior to study inclusion.
- Men and women with reproductive capacity should agree to use highly effective contraceptive methods during their participation in the study and in the 6 months following the last administration of plitidepsin.
- In addition, women participating in the study with reproductive ability must have a negative pregnancy test at enrollment.
Who cannot join
- Patients participating in some other clinical trial for COVID-19 infection.
- Patients who are receiving treatment with antivirals, interleukin 6 receptor inhibitors or immunomodulatory drugs for COVID-19.
- Patients who are receiving treatment with chloroquine and derivatives.
- Evidence of multi-organ failure.
- Patients who require support with mechanical ventilation (invasive or non-invasive) at the time of inclusion.
- D-dimer> 4 x UNL.
Show all 21Show fewer
- Hb <9 g / dL.
- Neutrophils <1000 / mm3.
- Platelets <100,000 / mm3.
- Lymphopenia <800 / μL.
- GOT / GPT> 3 X UNL.
- Bilirubin> 1 X UNL.
- CPK> 2.5 X UNL.
- Creatinine clearance <30ml / min.
- Troponin elevation> 1.5 x ULN.
- Clinically relevant heart disease (NYHA> 2).
- Clinically relevant arrhythmia or previous history / presence of prolonged QT-QTc ≥ 450 ms.
- Pre-existing neuropathies of any type ≥ grade 2.
- Hypersensitivity to the active substance or to any of its excipients (macrogol glycerol ricinoleate and ethanol).
- Patients who require or are being treated with potent CYP3A4 inhibitors and inducers.
- Patients who for any reason should not be included in the study according to the evaluation of the research team.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Hospital Germans Trias i Pujol
Badalona, 08916
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario Hm Montepríncipe
Boadilla del Monte, Madrid, 28660
Hospital Ciudad Real
Ciudad Real, 13005
Hospital Universitario de Getafe
Getafe, 28905
Hospital Universitario de Guadalajara
Guadalajara, 19002
Hospital Universitari Arnau de Vilanova
Lleida, 25198
Hospital La Princesa
Madrid, 28006
Hospital Gregorio Marañón
Madrid, 28009
Hospital Ramón Y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hosptial Quironsalud Madrid
Madrid, 28223
About this study
Official title: Multicenter, Randomized, Parallel and Proof of Concept Study to Evaluate the Safety Profile of Three Doses of Plitidepsin in Patients With COVID-19 Requiring Hospitalization
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay.
Given no specific antiviral therapy for COVID-19 and the ready availability of plitidepsin as a potential antiviral agent, based on pre-clinical studies, this randomized, parallel and proof of concept trial will evaluate the safety of three doses of plitidepsin in patients hospitalized with COVID-19.
Read the detailed description
In December 2019, a new infectious respiratory disease emerged in Wuhan, China. The agent that caused this pneumonia was identified as a new virus in the Coronaviridae family (SARS-CoV-2) and the clinical symptomatology associated with the virus has been named COVID-19. COVID-19 is currently a public health emergency.
Plitidepsin is an authorized drug in Australia for the treatment of multiple myeloma. Antiviral activity of plitidepsin has been analyzed in a human hepatoma cell line infected with the HCoV-229E-GFP virus, a virus similar to the SARS-CoV-2 virus.
Taking into account that the available safety data from plitidepsin comes from patients with solid tumors that received treatment with a regimen of administration of plitidepsin for 5 consecutive days, we propose a multicenter, randomized, proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin administered three consecutive days, in adult patients with confirmed diagnosis of COVID-19 who require hospital admission.
This study aims to assess safety and toxicity profile and also preliminary efficacy of plitidepsin at each dose level administered according to the proposed administration scheme in patients with COVID-19 who require hospital admission. Main objective is to select the recommended dose levels of plitidepsin for a future phase II / III efficacy study.
- Conditions
- COVID-19
- Being tested
- Plitidepsin 1.5 mg/day, Plitidepsin 2.0 mg/day, Plitidepsin 2.5 mg/day
- Keywords
- Plitidepsin, COVID-19, SARS-COV-2, Coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
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 will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
All patients must receive the following prophylactic medications 20-30 minutes before the infusion of plitidepsin:
- Diphenhydramine hydrochloride 25 mg iv or equivalent.
- Ranitidine 50 mg iv or equivalent.
- Dexamethasone 8 mg iv.
- Ondansetron 8 mg i.v. 15 minutes infusion or equivalent.
- Ondansetron 4 mg p.o. administered every 12 hours until 48 hours after the last administration of plitidepsin.
Plitidepsin 2.0 mg/dayDrug
Plitidepsin 2.0 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
All patients must receive the following prophylactic medications 20-30 minutes before the infusion of plitidepsin:
- Diphenhydramine hydrochloride 25 mg iv or equivalent.
- Ranitidine 50 mg iv or equivalent.
- Dexamethasone 8 mg iv.
- Ondansetron 8 mg i.v. 15 minutes infusion or equivalent.
- Ondansetron 4 mg p.o. administered every 12 hours until 48 hours after the last administration of plitidepsin.
Plitidepsin 2.5 mg/dayDrug
Plitidepsin 2.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
All patients must receive the following prophylactic medications 20-30 minutes before the infusion of plitidepsin:
- Diphenhydramine hydrochloride 25 mg iv or equivalent.
- Ranitidine 50 mg iv or equivalent.
- Dexamethasone 8 mg iv.
- Ondansetron 8 mg i.v. 15 minutes infusion or equivalent.
- Ondansetron 4 mg p.o. administered every 12 hours until 48 hours after the last administration of plitidepsin.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Plitidepsin 1.5 mg / day x 3 consecutive days Receives: Drug: Plitidepsin 1.5 mg/day |
| Experimental 2 | Experimental | Plitidepsin 2.0 mg / day x 3 consecutive days Receives: Drug: Plitidepsin 2.0 mg/day |
| Experimental 3 | Experimental | Plitidepsin 2.5 mg / day x 3 consecutive days Receives: Drug: Plitidepsin 2.5 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Occurrence of Neutropenia ≥ Grade 3
Percentage of patients with Neutropenia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Measured: At days 3, 7, 15 and 31
Frequency of Occurrence of Thrombocytopenia ≥ Grade 3
Percentage of patients with Thrombocytopenia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Measured: At days 3, 7, 15 and 31
Frequency of Occurrence of Anemia ≥ Grade 3
Percentage of patients with Anemia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Measured: At days 3, 7, 15 and 31
Frequency of Occurrence of Lymphopenia ≥ Grade 3
Percentage of patients with Lymphopenia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Measured: At days 3, 7, 15 and 31
Frequency of Occurrence of CPK Increase ≥ Grade 3
Percentage of patients with CPK increase ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Measured: At days 3, 7, 15 and 31
Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3
Percentage of patients with Increase ALT and / or AST ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Measured: At days 3, 7, 15 and 31
Frequency of Occurrence of Increase Total Bilirubin or Direct Bilirubin ≥ Grade 3
Percentage of patients with Increase total bilirubin or direct bilirubin ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Measured: At days 3, 7, 15 and 31
Frequency of Occurrence of Neurotoxicity ≥ Grade 3
Percentage of patients with Neurotoxicity ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Measured: At days 3, 7, 15 and 31
Frequency of Occurrence of QT-QTc Interval Extension ≥ Grade 3
Percentage of patients with QT-QTc interval extension ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Measured: At days 3, 7, 15 and 31
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Percentage of patients with Other adverse events ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Measured: At days 3, 7, 15 and 31.
Percentage of Patients in Whom Treatment Cannot be Completed.
Percentage of patients in whom treatment cannot be completed and the reasons.
Measured: At 3 days from the first dose of study treatment
Percentage of Patients With Adverse Events.
Percentage of patients with adverse events.
Measured: At days 3, 7, 15 and 31
Percentage of Patients With Serious Adverse Events.
Percentage of patients with serious adverse events.
Measured: At days 3, 7, 15 and 31
Percentage of Patients With ECG Abnormalities.
Percentage of patients with ECG abnormalities.
Measured: At days 2, 3, 4, 5, 6, 7, 15 and 31
Secondary outcomes (6)
Change in the Viral Load of SARS-CoV-2
Median change in the viral load of SARS-CoV-2 from baseline.
Measured: At days 4, 7, 15 and 31
Time to Negative PCR Test for COVID-19
Time from inclusion/randomization to date of negative PCR test for COVID-19
Measured: Up to 31 days + 3 days for window period
Mortality
Percentage of patients who die during the study
Measured: At days 7, 15 and 31
Percentage of Patients Requiring Invasive Mechanical Ventilation and / or ICU Admission
Percentage of patients requiring invasive mechanical ventilation and / or ICU admission
Measured: At days 7, 15 and 31
Percentage of Patients Requiring Non-invasive Mechanical Ventilation
Percentage of patients requiring non-invasive mechanical ventilation
Measured: At days 7, 15 and 31
Percentage of Patients Requiring Oxygen Therapy
Percentage of patients requiring oxygen therapy
Measured: At days 7, 15 and 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start12 May 2020
- Primary completion26 Nov 2020
- Study completion26 Nov 2020
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-19Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L.
- Responsible party
- Sponsor
- Investigators
- Vicente Estrada, MD, Principal investigator, Hospital San Carlos, MadridJesús Fortún, MD, Principal investigator, Hospital Universitario Ramon y CajalJosé Barberán, MD, Principal investigator, HOSPITAL UNIVERSITARIO HM MONTEPRÍNCIPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382066
- Sponsor's protocol ID
- APL-D-002-20
- Other IDs
- 2020-001993-31
- Acronym
- APLICOV-PC
- Status last verified
- Jul 2022
- First submitted
- 7 May 2020
- Last updated
- 23 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data of the final publication of the study will be shared upon request.
Publications
Varona JF, Landete P, Lopez-Martin JA, Estrada V, Paredes R, Guisado-Vasco P, Fernandez de Orueta L, Torralba M, Fortun J, Vates R, Barberan J, Clotet B, Ancochea J, Carnevali D, Cabello N, Porras L, Gijon P, Monereo A, Abad D, Zuniga S, Sola I, Rodon J, Vergara-Alert J, Izquierdo-Useros N, Fudio S, Pontes MJ, de Rivas B, Giron de Velasco P, Nieto A, Gomez J, Aviles P, Lubomirov R, Belgrano A, Sopesen B, White KM, Rosales R, Yildiz S, Reuschl AK, Thorne LG, Jolly C, Towers GJ, Zuliani-Alvarez L, Bouhaddou M, Obernier K, McGovern BL, Rodriguez ML, Enjuanes L, Fernandez-Sousa JM, Krogan NJ, Jimeno JM, Garcia-Sastre A. Preclinical and randomized phase I studies of plitidepsin in adults hospitalized with COVID-19. Life Sci Alliance. 2022 Jan 10;5(4):e202101200. doi: 10.26508/lsa.202101200. Print 2022 Apr.
PubMed 35012962
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Parallel and Proof of Concept Study to Evaluate the Safety Profile of Three Doses of Plitidepsin in Patients With COVID-19 Requiring Hospitalization
- ClinicalTrials.gov ID
- NCT04382066
- Acronym / sponsor ID
- APLICOV-PC / APL-D-002-20
- Conditions
- COVID-19
- Keywords
- Plitidepsin, COVID-19, SARS-COV-2, Coronavirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L.
- Study start
- 12 May 2020 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Posted 24 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay.
Given no specific antiviral therapy for COVID-19 and the ready availability of plitidepsin as a potential antiviral agent, based on pre-clinical studies, this randomized, parallel and proof of concept trial will evaluate the safety of three doses of plitidepsin in patients hospitalized with COVID-19.
Detailed description
In December 2019, a new infectious respiratory disease emerged in Wuhan, China. The agent that caused this pneumonia was identified as a new virus in the Coronaviridae family (SARS-CoV-2) and the clinical symptomatology associated with the virus has been named COVID-19. COVID-19 is currently a public health emergency.
Plitidepsin is an authorized drug in Australia for the treatment of multiple myeloma. Antiviral activity of plitidepsin has been analyzed in a human hepatoma cell line infected with the HCoV-229E-GFP virus, a virus similar to the SARS-CoV-2 virus.
Taking into account that the available safety data from plitidepsin comes from patients with solid tumors that received treatment with a regimen of administration of plitidepsin for 5 consecutive days, we propose a multicenter, randomized, proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin administered three consecutive days, in adult patients with confirmed diagnosis of COVID-19 who require hospital admission.
This study aims to assess safety and toxicity profile and also preliminary efficacy of plitidepsin at each dose level administered according to the proposed administration scheme in patients with COVID-19 who require hospital admission. Main objective is to select the recommended dose levels of plitidepsin for a future phase II / III efficacy study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: Plitidepsin 1.5 mg/dayPlitidepsin 1.5 mg / day x 3 consecutive days |
| Experimental 2 | Experimental | Drug: Plitidepsin 2.0 mg/dayPlitidepsin 2.0 mg / day x 3 consecutive days |
| Experimental 3 | Experimental | Drug: Plitidepsin 2.5 mg/dayPlitidepsin 2.5 mg / day x 3 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient who agrees to participate in the study by signing the informed consent.
- Men and women (non-pregnant) aged ≥18 years.
- COVID-19 infection confirmed by PCR obtained from nasopharyngeal exudate or sample from the lower respiratory tract.
- Patients who require hospitalization for COVID-19.
- Symptom onset at most within 10 days prior to study inclusion.
Key exclusion criteria (21 listed)
- Patients participating in some other clinical trial for COVID-19 infection.
- Patients who are receiving treatment with antivirals, interleukin 6 receptor inhibitors or immunomodulatory drugs for COVID-19.
- Patients who are receiving treatment with chloroquine and derivatives.
- Evidence of multi-organ failure.
- Patients who require support with mechanical ventilation (invasive or non-invasive) at the time of inclusion.
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 will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days. All patients must receive the following prophylactic medications 20-30 minutes before the infusion of plitidepsin: * Diphenhydramine hydrochloride 25 mg iv or equivalent. * Ranitidine 50 mg iv or equivalent. * Dexamethasone 8 mg iv. * Ondansetron 8 mg i.v. 15 minutes infusion or equivalent. * Ondansetron 4 mg p.o. administered every 12 hours until 48 hours after the last administration of plitidepsin. | Drug | Experimental 1 |
| Plitidepsin 2.0 mg/dayPlitidepsin 2.0 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days. All patients must receive the following prophylactic medications 20-30 minutes before the infusion of plitidepsin: * Diphenhydramine hydrochloride 25 mg iv or equivalent. * Ranitidine 50 mg iv or equivalent. * Dexamethasone 8 mg iv. * Ondansetron 8 mg i.v. 15 minutes infusion or equivalent. * Ondansetron 4 mg p.o. administered every 12 hours until 48 hours after the last administration of plitidepsin. | Drug | Experimental 2 |
| Plitidepsin 2.5 mg/dayPlitidepsin 2.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days. All patients must receive the following prophylactic medications 20-30 minutes before the infusion of plitidepsin: * Diphenhydramine hydrochloride 25 mg iv or equivalent. * Ranitidine 50 mg iv or equivalent. * Dexamethasone 8 mg iv. * Ondansetron 8 mg i.v. 15 minutes infusion or equivalent. * Ondansetron 4 mg p.o. administered every 12 hours until 48 hours after the last administration of plitidepsin. | Drug | Experimental 3 |
Primary outcome
Frequency of Occurrence of Neutropenia ≥ Grade 3
Time frame: At days 3, 7, 15 and 31
Percentage of patients with Neutropenia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Frequency of Occurrence of Thrombocytopenia ≥ Grade 3
Time frame: At days 3, 7, 15 and 31
Percentage of patients with Thrombocytopenia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Frequency of Occurrence of Anemia ≥ Grade 3
Time frame: At days 3, 7, 15 and 31
Percentage of patients with Anemia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Frequency of Occurrence of Lymphopenia ≥ Grade 3
Time frame: At days 3, 7, 15 and 31
Percentage of patients with Lymphopenia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Frequency of Occurrence of CPK Increase ≥ Grade 3
Time frame: At days 3, 7, 15 and 31
Percentage of patients with CPK increase ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3
Time frame: At days 3, 7, 15 and 31
Percentage of patients with Increase ALT and / or AST ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Frequency of Occurrence of Increase Total Bilirubin or Direct Bilirubin ≥ Grade 3
Time frame: At days 3, 7, 15 and 31
Percentage of patients with Increase total bilirubin or direct bilirubin ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Frequency of Occurrence of Neurotoxicity ≥ Grade 3
Time frame: At days 3, 7, 15 and 31
Percentage of patients with Neurotoxicity ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Frequency of Occurrence of QT-QTc Interval Extension ≥ Grade 3
Time frame: At days 3, 7, 15 and 31
Percentage of patients with QT-QTc interval extension ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Time frame: At days 3, 7, 15 and 31.
Percentage of patients with Other adverse events ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Percentage of Patients in Whom Treatment Cannot be Completed.
Time frame: At 3 days from the first dose of study treatment
Percentage of patients in whom treatment cannot be completed and the reasons.
Percentage of Patients With Adverse Events.
Time frame: At days 3, 7, 15 and 31
Percentage of patients with adverse events.
Percentage of Patients With Serious Adverse Events.
Time frame: At days 3, 7, 15 and 31
Percentage of patients with serious adverse events.
Percentage of Patients With ECG Abnormalities.
Time frame: At days 2, 3, 4, 5, 6, 7, 15 and 31
Percentage of patients with ECG abnormalities.
6 secondary outcomes
Change in the Viral Load of SARS-CoV-2
Time frame: At days 4, 7, 15 and 31
Time to Negative PCR Test for COVID-19
Time frame: Up to 31 days + 3 days for window period
Mortality
Time frame: At days 7, 15 and 31
Percentage of Patients Requiring Invasive Mechanical Ventilation and / or ICU Admission
Time frame: At days 7, 15 and 31
Percentage of Patients Requiring Non-invasive Mechanical Ventilation
Time frame: At days 7, 15 and 31
Percentage of Patients Requiring Oxygen Therapy
Time frame: At days 7, 15 and 31
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35012962Varona JF, Landete P, Lopez-Martin JA, Estrada V, Paredes R, Guisado-Vasco P, Fernandez de Orueta L, Torralba M, Fortun J, Vates R, Barberan J, Clotet B, Ancochea J, Carnevali D, Cabello N, Porras L, Gijon P, Monereo A, Abad D, Zuniga S, Sola I, Rodon J, Vergara-Alert J, Izquierdo-Useros N, Fudio S, Pontes MJ, de Rivas B, Giron de Velasco P, Nieto A, Gomez J, Aviles P, Lubomirov R, Belgrano A, Sopesen B, White KM, Rosales R, Yildiz S, Reuschl AK, Thorne LG, Jolly C, Towers GJ, Zuliani-Alvarez L, Bouhaddou M, Obernier K, McGovern BL, Rodriguez ML, Enjuanes L, Fernandez-Sousa JM, Krogan NJ, Jimeno JM, Garcia-Sastre A. Preclinical and randomized phase I studies of plitidepsin in adults hospitalized with COVID-19. Life Sci Alliance. 2022 Jan 10;5(4):e202101200. doi: 10.26508/lsa.202101200. Print 2022 Apr.
- Individual participant dataSharing planned: Yes. Data of the final publication of the study will be shared upon request.
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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.
Vicente Estrada, MD principal investigator
Hospital San Carlos, Madrid
Jesús Fortún, MD principal investigator
Hospital Universitario Ramon y Cajal
José Barberán, MD principal investigator
HOSPITAL UNIVERSITARIO HM MONTEPRÍNCIPE
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Plitidepsin 1.5 mg/day, Plitidepsin 2.0 mg/day and Plitidepsin 2.5 mg/day in people with COVID-19, run by PharmaMar at 13 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 7 inclusion and 21 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 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 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.
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 24 Sep 2021). 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?
Frequency of Occurrence of Neutropenia ≥ Grade 3 (time frame: At days 3, 7, 15 and 31). The study lists 14 primary outcomes in all. 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 NCT04382066, 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 23 Aug 2022.