Trial Outcomes & Findings for Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19 (NCT NCT04382066)
NCT ID: NCT04382066
Last Updated: 2022-08-23
Results Overview
Percentage of patients with Neutropenia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
At days 3, 7, 15 and 31
Results posted on
2022-08-23
Participant Flow
Participant milestones
| Measure |
Experimental 1
Plitidepsin 1.5 mg / day x 3 consecutive days
Plitidepsin 1.5 mg/day: Plitidepsin 1.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
|
Experimental 2
Plitidepsin 2.0 mg / day x 3 consecutive days
Plitidepsin 2.0 mg/day: Plitidepsin 2.0 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
|
Experimental 3
Plitidepsin 2.5 mg / day x 3 consecutive days
Plitidepsin 2.5 mg/day: Plitidepsin 2.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
Completed 3-day Treatment
|
14
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Experimental 1
Plitidepsin 1.5 mg / day x 3 consecutive days
Plitidepsin 1.5 mg/day: Plitidepsin 1.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
|
Experimental 2
Plitidepsin 2.0 mg / day x 3 consecutive days
Plitidepsin 2.0 mg/day: Plitidepsin 2.0 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
|
Experimental 3
Plitidepsin 2.5 mg / day x 3 consecutive days
Plitidepsin 2.5 mg/day: Plitidepsin 2.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
1
|
Baseline Characteristics
Oxygen saturation at room air has been analyzed for the 22 patients who did not requiere supplementary O2.
Baseline characteristics by cohort
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
Plitidepsin 1.5 mg/day: Plitidepsin 1.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
Plitidepsin 2.0 mg/day: Plitidepsin 2.0 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
Plitidepsin 2.5 mg/day: Plitidepsin 2.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=15 Participants
|
13 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
36 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
4 Participants
n=15 Participants
|
9 Participants
n=45 Participants
|
|
Age, Continuous
|
51 years
n=15 Participants
|
49 years
n=15 Participants
|
53 years
n=15 Participants
|
52 years
n=45 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=15 Participants
|
4 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
15 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
30 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
45 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=45 Participants
|
|
Region of Enrollment
Spain
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
45 participants
n=45 Participants
|
|
Number of comorbidities
None
|
5 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
9 Participants
n=45 Participants
|
|
Number of comorbidities
One
|
2 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
15 Participants
n=45 Participants
|
|
Number of comorbidities
Two or more
|
8 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
21 Participants
n=45 Participants
|
|
Comorbidities
Cardiac disease
|
1 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=45 Participants
|
|
Comorbidities
Kidney disease
|
0 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=45 Participants
|
|
Comorbidities
Lung disease (COPD)
|
1 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
3 Participants
n=45 Participants
|
|
Comorbidities
Asthma
|
2 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
5 Participants
n=45 Participants
|
|
Comorbidities
Diabetes
|
1 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
8 Participants
n=45 Participants
|
|
Comorbidities
Hypertension
|
2 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
9 Participants
n=45 Participants
|
|
Comorbidities
Obesity
|
1 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
4 Participants
n=15 Participants
|
10 Participants
n=45 Participants
|
|
Clinical status at randomization
Mild COVID-19 infection
|
2 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
6 Participants
n=45 Participants
|
|
Clinical status at randomization
Moderate COVID-19 infection
|
8 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
23 Participants
n=45 Participants
|
|
Clinical status at randomization
Severe COVID-19 infection
|
5 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
16 Participants
n=45 Participants
|
|
Chest x-rays
Abnormal
|
15 Participants
n=15 Participants
|
13 Participants
n=15 Participants
|
13 Participants
n=15 Participants
|
41 Participants
n=45 Participants
|
|
Chest x-rays
Bilateral pneumonia
|
11 Participants
n=15 Participants
|
10 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
32 Participants
n=45 Participants
|
|
Body temperature
|
36.5 Degrees Celsius
n=15 Participants
|
37.0 Degrees Celsius
n=15 Participants
|
36.2 Degrees Celsius
n=15 Participants
|
36.5 Degrees Celsius
n=45 Participants
|
|
Systolic blood pressure
|
113 mmHg
n=15 Participants
|
115 mmHg
n=15 Participants
|
124 mmHg
n=15 Participants
|
119 mmHg
n=45 Participants
|
|
Diastolic blood pressure
|
69 mmHg
n=15 Participants
|
71 mmHg
n=15 Participants
|
78 mmHg
n=15 Participants
|
72 mmHg
n=45 Participants
|
|
Heart rate
|
84 Bpm
n=15 Participants
|
78 Bpm
n=15 Participants
|
82 Bpm
n=15 Participants
|
82 Bpm
n=45 Participants
|
|
Respiratory rate
|
17 Bpm
n=15 Participants
|
18 Bpm
n=15 Participants
|
16.5 Bpm
n=15 Participants
|
17 Bpm
n=45 Participants
|
|
Oxygen saturation at room air
|
95 Percentage
n=9 Participants • Oxygen saturation at room air has been analyzed for the 22 patients who did not requiere supplementary O2.
|
95 Percentage
n=7 Participants • Oxygen saturation at room air has been analyzed for the 22 patients who did not requiere supplementary O2.
|
96.5 Percentage
n=6 Participants • Oxygen saturation at room air has been analyzed for the 22 patients who did not requiere supplementary O2.
|
95.5 Percentage
n=22 Participants • Oxygen saturation at room air has been analyzed for the 22 patients who did not requiere supplementary O2.
|
|
On supplementary O2
|
6 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
9 Participants
n=15 Participants
|
23 Participants
n=45 Participants
|
|
PaO2/FiO2
|
358 Ratio
n=15 Participants
|
352 Ratio
n=15 Participants
|
343 Ratio
n=15 Participants
|
350 Ratio
n=45 Participants
|
|
White Blood Cells (WBC)
|
4.4 10^9 cells/liter
n=15 Participants
|
5.4 10^9 cells/liter
n=15 Participants
|
7.1 10^9 cells/liter
n=15 Participants
|
5.5 10^9 cells/liter
n=45 Participants
|
|
Platelet count
|
183 10^9 cells/liter
n=15 Participants
|
168 10^9 cells/liter
n=15 Participants
|
244 10^9 cells/liter
n=15 Participants
|
183 10^9 cells/liter
n=45 Participants
|
|
Lymphocytes
|
0.9 10^9 cells/liter
n=15 Participants
|
1.1 10^9 cells/liter
n=15 Participants
|
1.1 10^9 cells/liter
n=15 Participants
|
1.0 10^9 cells/liter
n=45 Participants
|
|
D-dimer
|
330 ng/mL
n=15 Participants
|
463 ng/mL
n=15 Participants
|
415 ng/mL
n=15 Participants
|
405 ng/mL
n=45 Participants
|
|
Ferritin
|
408 ng/ml
n=15 Participants
|
597 ng/ml
n=15 Participants
|
363 ng/ml
n=15 Participants
|
412 ng/ml
n=45 Participants
|
|
C-reactive protein
|
17.7 mg/L
n=15 Participants
|
67.2 mg/L
n=15 Participants
|
32.6 mg/L
n=15 Participants
|
32.7 mg/L
n=45 Participants
|
|
Serum creatinine
|
0.8 mg/dL
n=15 Participants
|
0.8 mg/dL
n=15 Participants
|
0.8 mg/dL
n=15 Participants
|
0.8 mg/dL
n=45 Participants
|
|
Alanine aminotransferase
|
0.9 x Upper Limit of Normal (ULN)
n=15 Participants
|
0.8 x Upper Limit of Normal (ULN)
n=15 Participants
|
0.7 x Upper Limit of Normal (ULN)
n=15 Participants
|
0.8 x Upper Limit of Normal (ULN)
n=45 Participants
|
|
Aspartate aminotransferase
|
0.8 x Upper Limit of Normal (ULN)
n=15 Participants
|
0.9 x Upper Limit of Normal (ULN)
n=15 Participants
|
0.7 x Upper Limit of Normal (ULN)
n=15 Participants
|
0.8 x Upper Limit of Normal (ULN)
n=45 Participants
|
|
Lactate dehydrogenase
|
1.0 x Upper Limit of Normal (ULN)
n=15 Participants
|
1.0 x Upper Limit of Normal (ULN)
n=15 Participants
|
1.2 x Upper Limit of Normal (ULN)
n=15 Participants
|
1.0 x Upper Limit of Normal (ULN)
n=45 Participants
|
|
Creatine phosphokinase
|
0.4 x Upper Limit of Normal (ULN)
n=15 Participants
|
0.3 x Upper Limit of Normal (ULN)
n=15 Participants
|
0.4 x Upper Limit of Normal (ULN)
n=15 Participants
|
0.4 x Upper Limit of Normal (ULN)
n=45 Participants
|
|
Viral load
|
6.3 Log10 copies/mL
n=15 Participants • Results available por 44 patients: 1 patient (in 2.0 mg cohort) did not have baseline viral load asessment by central lab.
|
6.2 Log10 copies/mL
n=14 Participants • Results available por 44 patients: 1 patient (in 2.0 mg cohort) did not have baseline viral load asessment by central lab.
|
5.7 Log10 copies/mL
n=15 Participants • Results available por 44 patients: 1 patient (in 2.0 mg cohort) did not have baseline viral load asessment by central lab.
|
6.1 Log10 copies/mL
n=44 Participants • Results available por 44 patients: 1 patient (in 2.0 mg cohort) did not have baseline viral load asessment by central lab.
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31Percentage of patients with Neutropenia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Frequency of Occurrence of Neutropenia ≥ Grade 3
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Neutropenia ≥ Grade 3
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Neutropenia ≥ Grade 3
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Neutropenia ≥ Grade 3
Day 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31Percentage of patients with Thrombocytopenia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Frequency of Occurrence of Thrombocytopenia ≥ Grade 3
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Thrombocytopenia ≥ Grade 3
Day 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Thrombocytopenia ≥ Grade 3
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Thrombocytopenia ≥ Grade 3
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31Percentage of patients with Anemia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Frequency of Occurrence of Anemia ≥ Grade 3
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Anemia ≥ Grade 3
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Anemia ≥ Grade 3
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Anemia ≥ Grade 3
Day 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31Percentage of patients with Lymphopenia ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Frequency of Occurrence of Lymphopenia ≥ Grade 3
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Lymphopenia ≥ Grade 3
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Lymphopenia ≥ Grade 3
Day 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Lymphopenia ≥ Grade 3
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31Percentage of patients with CPK increase ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Frequency of Occurrence of CPK Increase ≥ Grade 3
Day 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of CPK Increase ≥ Grade 3
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of CPK Increase ≥ Grade 3
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of CPK Increase ≥ Grade 3
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31Percentage of patients with Increase ALT and / or AST ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3
ALT increased Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3
ALT increased Day 15
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3
ALT increased Day 31
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3
AST increased Day 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3
ALT increased Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3
AST increased Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3
AST increased Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3
AST increased Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31Percentage of patients with Increase total bilirubin or direct bilirubin ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Frequency of Occurrence of Increase Total Bilirubin or Direct Bilirubin ≥ Grade 3
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Increase Total Bilirubin or Direct Bilirubin ≥ Grade 3
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Increase Total Bilirubin or Direct Bilirubin ≥ Grade 3
Day 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Increase Total Bilirubin or Direct Bilirubin ≥ Grade 3
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31Percentage of patients with Neurotoxicity ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Frequency of Occurrence of Neurotoxicity ≥ Grade 3
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Neurotoxicity ≥ Grade 3
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Neurotoxicity ≥ Grade 3
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Neurotoxicity ≥ Grade 3
Day 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31Percentage of patients with QT-QTc interval extension ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Frequency of Occurrence of QT-QTc Interval Extension ≥ Grade 3
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of QT-QTc Interval Extension ≥ Grade 3
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of QT-QTc Interval Extension ≥ Grade 3
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of QT-QTc Interval Extension ≥ Grade 3
Day 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31.Percentage of patients with Other adverse events ≥ grade 3 according to NCI-CTCAE v5.0 criteria.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Leukocytosis day 31
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Diarrhoea day 3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Condition aggravated day 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Condition aggravated day 7
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Anaphylactic reaction day 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Anaphylactic reaction day 7
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Bacteraemia day 7
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Bacteraemia day 15
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
COVID-19 pneumonia day 7
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
COVID-19 pneumonia day 15
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
COVID-19 pneumonia day 31
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Superinfection bacterial day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Superinfection bacterial day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Urinary tract infection day 31
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
C-reactive protein increased day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
C-reactive protein increased day 7
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
C-reactive protein increased day 15
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
C-reactive protein increased day 31
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Gamma-glutamyltransferase increased day 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Gamma-glutamyltransferase increased day 7
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Gamma-glutamyltransferase increased day 15
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Gamma-glutamyltransferase increased day 31
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Serum ferritin increased day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Serum ferritin increased day 31
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Hyperglycaemia day 3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Hyperglycaemia day 7
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Status epilepticus day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Status epilepticus day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Acute respiratory distress syndrome day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Acute respiratory distress syndrome day 7
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Acute respiratory distress syndrome day 15
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Leukocytosis day 3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Leukocytosis day 7
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Leukocytosis day 15
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Diarrhoea day 7
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Diarrhoea day 15
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Diarrhoea day 31
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Condition aggravated day 15
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Condition aggravated day 31
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Anaphylactic reaction day 15
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Anaphylactic reaction day 31
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Bacteraemia day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Bacteraemia day 31
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
COVID-19 pneumonia day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Pneumonia day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Pneumonia day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Pneumonia day 15
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Pneumonia day 31
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Superinfection bacterial day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Superinfection bacterial day 31
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Urinary tract infection day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Urinary tract infection day 7
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Urinary tract infection day 15
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Serum ferritin increased day 7
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Serum ferritin increased day 15
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Hyperglycaemia day 15
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Hyperglycaemia day 31
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Status epilepticus day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Status epilepticus day 31
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Acute respiratory distress syndrome day 31
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Pneumomediastinum day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Pneumomediastinum day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Pneumomediastinum day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Pneumomediastinum day 31
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Respiratory distress day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Respiratory distress day 7
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Respiratory distress day 15
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Occurrence of Other Adverse Events ≥ Grade 3
Respiratory distress day 31
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At 3 days from the first dose of study treatmentPercentage of patients in whom treatment cannot be completed and the reasons.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Percentage of Patients in Whom Treatment Cannot be Completed.
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31Percentage of patients with adverse events.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Percentage of Patients With Adverse Events.
Day 3
|
14 Participants
|
11 Participants
|
13 Participants
|
38 Participants
|
|
Percentage of Patients With Adverse Events.
Day 7
|
15 Participants
|
14 Participants
|
15 Participants
|
44 Participants
|
|
Percentage of Patients With Adverse Events.
Day 15
|
15 Participants
|
14 Participants
|
15 Participants
|
44 Participants
|
|
Percentage of Patients With Adverse Events.
Day 31
|
15 Participants
|
14 Participants
|
15 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: At days 3, 7, 15 and 31Percentage of patients with serious adverse events.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Percentage of Patients With Serious Adverse Events.
Day 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Percentage of Patients With Serious Adverse Events.
Day 7
|
4 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Percentage of Patients With Serious Adverse Events.
Day 15
|
4 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
|
Percentage of Patients With Serious Adverse Events.
Day 31
|
6 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: At days 2, 3, 4, 5, 6, 7, 15 and 31Percentage of patients with ECG abnormalities.
Outcome measures
| Measure |
Experimental 1
n=15 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Percentage of Patients With ECG Abnormalities.
Day 6
|
4 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
|
Percentage of Patients With ECG Abnormalities.
Day 2
|
2 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
|
Percentage of Patients With ECG Abnormalities.
Day 3
|
4 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
|
Percentage of Patients With ECG Abnormalities.
Day 4
|
3 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Percentage of Patients With ECG Abnormalities.
Day 5
|
3 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
|
Percentage of Patients With ECG Abnormalities.
Day 7
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Percentage of Patients With ECG Abnormalities.
Day 15
|
2 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Percentage of Patients With ECG Abnormalities.
Day 31
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At days 4, 7, 15 and 31Population: One patient dosed at 1.5 mg experienced an anaphylactic reaction during the first plitidepsin infusion and discontinued study treatment, so was not considered evaluable for efficacy.
Median change in the viral load of SARS-CoV-2 from baseline.
Outcome measures
| Measure |
Experimental 1
n=14 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=44 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Change in the Viral Load of SARS-CoV-2
Day 4
|
-1.23 Log10 copies/mL
Standard Deviation 1.30
|
-1.49 Log10 copies/mL
Standard Deviation 1.42
|
-1.32 Log10 copies/mL
Standard Deviation 1.90
|
-1.35 Log10 copies/mL
Standard Deviation 1.54
|
|
Change in the Viral Load of SARS-CoV-2
Day 7
|
-2.55 Log10 copies/mL
Standard Deviation 1.65
|
-2.26 Log10 copies/mL
Standard Deviation 1.68
|
-2.25 Log10 copies/mL
Standard Deviation 1.61
|
-2.35 Log10 copies/mL
Standard Deviation 1.61
|
|
Change in the Viral Load of SARS-CoV-2
Day 15
|
-4.22 Log10 copies/mL
Standard Deviation 2.58
|
-2.70 Log10 copies/mL
Standard Deviation 2.23
|
-2.92 Log10 copies/mL
Standard Deviation 1.91
|
-3.25 Log10 copies/mL
Standard Deviation 2.29
|
|
Change in the Viral Load of SARS-CoV-2
Day 31
|
-4.70 Log10 copies/mL
Standard Deviation 1.74
|
-3.53 Log10 copies/mL
Standard Deviation 2.07
|
-3.49 Log10 copies/mL
Standard Deviation 2.94
|
-3.85 Log10 copies/mL
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: Up to 31 days + 3 days for window periodPopulation: One patient dosed at 1.5 mg experienced an anaphylactic reaction during the first plitidepsin infusion and discontinued study treatment, so was not considered evaluable for efficacy.
Time from inclusion/randomization to date of negative PCR test for COVID-19
Outcome measures
| Measure |
Experimental 1
n=14 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=44 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Time to Negative PCR Test for COVID-19
|
11 Days
Interval 3.0 to 29.0
|
14 Days
Interval 3.0 to 30.0
|
14 Days
Interval 3.0 to 33.0
|
13 Days
Interval 3.0 to 33.0
|
SECONDARY outcome
Timeframe: At days 7, 15 and 31Population: One patient dosed at 1.5 mg experienced an anaphylactic reaction during the first plitidepsin infusion and discontinued study treatment, so was not considered evaluable for efficacy.
Percentage of patients who die during the study
Outcome measures
| Measure |
Experimental 1
n=14 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=44 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Mortality
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Mortality
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Mortality
Day 31
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At days 7, 15 and 31Population: One patient dosed at 1.5 mg experienced an anaphylactic reaction during the first plitidepsin infusion and discontinued study treatment, so was not considered evaluable for efficacy. Cumulative results.
Percentage of patients requiring invasive mechanical ventilation and / or ICU admission
Outcome measures
| Measure |
Experimental 1
n=14 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=44 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Percentage of Patients Requiring Invasive Mechanical Ventilation and / or ICU Admission
Day 31
|
2 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Percentage of Patients Requiring Invasive Mechanical Ventilation and / or ICU Admission
Day 7
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Percentage of Patients Requiring Invasive Mechanical Ventilation and / or ICU Admission
Day 15
|
2 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At days 7, 15 and 31Population: One patient dosed at 1.5 mg experienced an anaphylactic reaction during the first plitidepsin infusion and discontinued study treatment, so was not considered evaluable for efficacy. Cumulative results.
Percentage of patients requiring non-invasive mechanical ventilation
Outcome measures
| Measure |
Experimental 1
n=14 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=44 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Percentage of Patients Requiring Non-invasive Mechanical Ventilation
Day 31
|
5 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
|
Percentage of Patients Requiring Non-invasive Mechanical Ventilation
Day 7
|
4 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Percentage of Patients Requiring Non-invasive Mechanical Ventilation
Day 15
|
5 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At days 7, 15 and 31Population: One patient dosed at 1.5 mg experienced an anaphylactic reaction during the first plitidepsin infusion and discontinued study treatment, so was not considered evaluable for efficacy. Cumulative results.
Percentage of patients requiring oxygen therapy
Outcome measures
| Measure |
Experimental 1
n=14 Participants
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 Participants
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 Participants
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=44 Participants
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Percentage of Patients Requiring Oxygen Therapy
Day 7
|
12 Participants
|
12 Participants
|
11 Participants
|
35 Participants
|
|
Percentage of Patients Requiring Oxygen Therapy
Day 15
|
12 Participants
|
12 Participants
|
11 Participants
|
35 Participants
|
|
Percentage of Patients Requiring Oxygen Therapy
Day 31
|
12 Participants
|
12 Participants
|
11 Participants
|
35 Participants
|
Adverse Events
Experimental 1
Serious events: 6 serious events
Other events: 15 other events
Deaths: 1 deaths
Experimental 2
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Experimental 3
Serious events: 3 serious events
Other events: 15 other events
Deaths: 1 deaths
Total
Serious events: 10 serious events
Other events: 44 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Experimental 1
n=15 participants at risk
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 participants at risk
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 participants at risk
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 participants at risk
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
13.3%
2/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
8.9%
4/45 • Number of events 5 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
General disorders
Condition aggravated
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Infections and infestations
Pyelonephritis
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Infections and infestations
COVID-19 pneumonia
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
Other adverse events
| Measure |
Experimental 1
n=15 participants at risk
Plitidepsin 1.5 mg / day x 3 consecutive days
|
Experimental 2
n=15 participants at risk
Plitidepsin 2.0 mg / day x 3 consecutive days
|
Experimental 3
n=15 participants at risk
Plitidepsin 2.5 mg / day x 3 consecutive days
|
Total
n=45 participants at risk
All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety.
|
|---|---|---|---|---|
|
Investigations
GGT increased
|
20.0%
3/15 • Number of events 8 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 5 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
6/45 • Number of events 14 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
LDH increased
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
8.9%
4/45 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
26.7%
4/15 • Number of events 5 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
26.7%
4/15 • Number of events 7 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
17.8%
8/45 • Number of events 12 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Hepatobiliary disorders
Hypoalbuminaemia
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Infections and infestations
COVID-19 pneumonia
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Infections and infestations
Skin candida
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Infections and infestations
Viral infection
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Alkaline phosphatase increased
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
ALT increased
|
13.3%
2/15 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
11.1%
5/45 • Number of events 9 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Amylase increased
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
AST increased
|
6.7%
1/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
3/45 • Number of events 5 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Blood glucose increased
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
CPK increased
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
C-reactive protein increased
|
26.7%
4/15 • Number of events 8 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
26.7%
4/15 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
20.0%
3/15 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
24.4%
11/45 • Number of events 16 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Ferritin increased
|
33.3%
5/15 • Number of events 11 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
26.7%
4/15 • Number of events 6 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
33.3%
5/15 • Number of events 5 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
31.1%
14/45 • Number of events 22 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
20.0%
3/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
3/45 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.7%
1/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
3/45 • Number of events 5 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
8.9%
4/45 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Gastrointestinal disorders
Constipation
|
26.7%
4/15 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
17.8%
8/45 • Number of events 8 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
26.7%
4/15 • Number of events 6 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
20.0%
3/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
17.8%
8/45 • Number of events 10 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
8.9%
4/45 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Number of events 9 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
40.0%
6/15 • Number of events 7 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
46.7%
7/15 • Number of events 9 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
42.2%
19/45 • Number of events 25 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
LDL increased
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Oxygen saturation decreased
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Transaminases increased
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Triglycerides increased
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Fibrin D dimer increased
|
20.0%
3/15 • Number of events 5 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
20.0%
3/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
17.8%
8/45 • Number of events 11 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
1/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
3/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
20.0%
3/15 • Number of events 7 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
17.8%
8/45 • Number of events 13 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
3/45 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Number of events 5 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
6/45 • Number of events 8 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Nervous system disorders
Insomnia
|
13.3%
2/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
8.9%
4/45 • Number of events 5 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Nervous system disorders
Migraine
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Nervous system disorders
Paraesthesia
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Nervous system disorders
Presyncope
|
20.0%
3/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
8.9%
4/45 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Renal and urinary disorders
Pollakiuria
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Renal and urinary disorders
Prerenal failure
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Reproductive system and breast disorders
Breast engorgement
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
4/15 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
20.0%
3/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
26.7%
4/15 • Number of events 5 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
24.4%
11/45 • Number of events 12 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
3/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
15.6%
7/45 • Number of events 7 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
4.4%
2/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Vascular disorders
Phlebitis
|
20.0%
3/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
20.0%
3/15 • Number of events 5 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 2 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
17.8%
8/45 • Number of events 10 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Vascular disorders
Thrombophlebitis
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
General disorders
Asthenia
|
20.0%
3/15 • Number of events 4 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
2/15 • Number of events 3 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
13.3%
6/45 • Number of events 10 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
General disorders
Chest discomfort
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
General disorders
Pyrexia
|
53.3%
8/15 • Number of events 10 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
33.3%
5/15 • Number of events 12 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
46.7%
7/15 • Number of events 17 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
44.4%
20/45 • Number of events 39 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
General disorders
Malaise
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
General disorders
Fatigue
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Interleukin level increased
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Investigations
Lipase increased
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
6.7%
1/15 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
0.00%
0/15 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
2.2%
1/45 • Number of events 1 • From first administration of plitidepsin until day 31.
2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
|
Additional Information
Clinical Development Virology Business Unit PharmaMar
PharmaMar, S.A.
Phone: +34 91 846 60 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60