COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04382066

Vicente Estrada

vicente.estrada@salud.madrid.org

2020-05-11

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: 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.

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.

3

PharmaMar

18

None

Spain

Moderate disease at enrollment

3: Moderate disease at enrollment

46

Frequency of occurrence of Anemia ≥ grade 3;Frequency of occurrence of CPK increase ≥ grade 3;Percentage of patients with ECG abnormalities.;Percentage of patients with serious adverse events.;Frequency of occurrence of Increase ALT and / or AST ≥ grade 3;Frequency of occurrence of Increase total bilirubin or direct bilirubin ≥ grade 3;Frequency of occurrence of Neutropenia ≥ grade 3;Percentage of patients with adverse events.;Frequency of occurrence of Thrombocytopenia ≥ grade 3;Frequency of occurrence of Lymphopenia ≥ grade 3;Frequency of occurrence of QT-QTc interval extension ≥ grade 3;Frequency of occurrence of Neurotoxicity ≥ grade 3;Percentage of patients in whom treatment cannot be completed.;Frequency of occurrence of Other adverse events ≥ grade 3

None

Phase 1

[{"arm_notes": "", "treatment_id": 1003, "treatment_name": "Plitidepsin", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1003, "treatment_name": "Plitidepsin", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1003, "treatment_name": "Plitidepsin", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}]