Status:
COMPLETED
Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19
Lead Sponsor:
PharmaMar
Collaborating Sponsors:
Apices Soluciones S.L.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 coro...
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 clin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2020
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04382066
Start Date
May 12 2020
End Date
November 26 2020
Last Update
August 23 2022
Active Locations (13)
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1
Hospital Universitario Hm Montepríncipe
Boadilla del Monte, Madrid, Spain, 28660
2
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
3
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041