Trial Outcomes & Findings for Extension Study in a Cohort of Adult Patients With COVID-19 Infection (NCT NCT05121740)
NCT ID: NCT05121740
Last Updated: 2024-12-31
Results Overview
Number and percentage of patients who developed complications related to post COVID-19 infection
COMPLETED
PHASE1/PHASE2
34 participants
Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
2024-12-31
Participant Flow
Patients were included in the study between 25th January 2022 and 28th February 2022.
All patients who participated in and received plitidepsin in the APLICOV-PC study are eligible candidates for participating in this extension study.
Participant milestones
| Measure |
Arm A: Experimental 1
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
2.5 mg of plitidepsin / day
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
14
|
11
|
|
Overall Study
COMPLETED
|
9
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extension Study in a Cohort of Adult Patients With COVID-19 Infection
Baseline characteristics by cohort
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
52.5 years
n=7 Participants
|
54 years
n=5 Participants
|
53 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Latin
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
North African
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Weight
|
80.0 Kg
n=5 Participants
|
88.5 Kg
n=7 Participants
|
86.0 Kg
n=5 Participants
|
84.8 Kg
n=4 Participants
|
|
Height
|
170.0 cm
n=5 Participants
|
169.0 cm
n=7 Participants
|
161.0 cm
n=5 Participants
|
168.4 cm
n=4 Participants
|
|
Body Surface Area
|
1.9 m^2
n=5 Participants
|
2.0 m^2
n=7 Participants
|
1.9 m^2
n=5 Participants
|
1.9 m^2
n=4 Participants
|
PRIMARY outcome
Timeframe: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.Number and percentage of patients who developed complications related to post COVID-19 infection
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Number and Percentage of Participants With Complications Related to Post COVID-19 Infection
|
4 Participants
|
8 Participants
|
5 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.Percentage of patients requiring oxygen therapy
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Patients Requiring Oxygen Therapy
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months..Percentage of patients with complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not).
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not).
Without complications
|
1 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
|
Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not).
Regardless relationship, i.e. related to COVID-19 infection or not.
|
8 Participants
|
12 Participants
|
6 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.PaO2/FiO2 (Ratio of partial pressure arterial oxygen and fraction of inspired oxygen) mean, standard deviation. PaO2/FiO2 ratio to evaluate disease severity and discriminate between 'Moderate' and 'Severe' categories according to FDA guidance.
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2)
|
472.0 Ratio
Standard Deviation 85.9
|
464.2 Ratio
Standard Deviation 90.3
|
518.7 Ratio
Standard Deviation 99.1
|
482.8 Ratio
Standard Deviation 92.2
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.FEV1 (Forced expiratory volume 1) mean, standard deviation.
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Forced Expiratory Volume 1 (FEV1)
|
3052 ml
Standard Deviation 865.4
|
3267 ml
Standard Deviation 774.9
|
2857 ml
Standard Deviation 1029
|
3078 ml
Standard Deviation 877.9
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.Lung difussion testing: mean and standard deviation. Unit of measure: % reference theoretical value
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Lung Diffusion Testing
|
98.4 Percentage reference theoretical value
Standard Deviation 11.4
|
100.1 Percentage reference theoretical value
Standard Deviation 24.0
|
105.2 Percentage reference theoretical value
Standard Deviation 15.2
|
101.3 Percentage reference theoretical value
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.Percentage of patients with alterations in chest radiography
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Patients With Alterations in Chest Radiography
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.Percentage of patients with electrocardiogram alterations
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Patients With Electrocardiogram Alterations
|
1 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.Percentage of patients with ≥grade 2 alterations in laboratory parameters Grade measured according to NCI-CTCAE v5.0 (National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0) where Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL\* Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Patients With ≥Grade 2 Alterations in Laboratory Parameters
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.Percentage of patients in each category of the Modified Medical Research Council (mMRC) dyspnea scale. The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1. shortness of breath when hurrying on the level or walking up a slight hill; 2. walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3. stops for breath after walking ∼100 m or after few minutes on the level; and 4. too breathless to leave the house, or breathless when dressing or undressing.
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Modified Medical Research Council (mMRC) Dyspnea Scale
3
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Modified Medical Research Council (mMRC) Dyspnea Scale
0
|
5 Participants
|
7 Participants
|
9 Participants
|
21 Participants
|
|
Modified Medical Research Council (mMRC) Dyspnea Scale
1
|
2 Participants
|
6 Participants
|
2 Participants
|
10 Participants
|
|
Modified Medical Research Council (mMRC) Dyspnea Scale
2
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.FEV1/FVC mean, standard deviation.
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
FEV1/FVC
|
79.9 Ratio
Standard Deviation 5.8
|
79.3 Ratio
Standard Deviation 8.6
|
78.1 Ratio
Standard Deviation 13.0
|
79.1 Ratio
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.FVC mean, standard deviation.
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Forced Vital Capacity (FVC)
|
3809 ml
Standard Deviation 1022
|
4107 ml
Standard Deviation 827.2
|
3751 ml
Standard Deviation 1222
|
3913 ml
Standard Deviation 1001
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.SaO2 (Arterial oxygen saturation) mean, standard deviation. Unit of measure: percentage of oxygen saturation
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Arterial Oxygen Saturation (SaO2)
|
97.2 Percentage of oxygen saturation
Standard Deviation 1.8
|
97.1 Percentage of oxygen saturation
Standard Deviation 1.7
|
98.1 Percentage of oxygen saturation
Standard Deviation 1.2
|
97.4 Percentage of oxygen saturation
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.The Barthel index measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Percentage of patients at each category according to the score obtained: 0-20: Total dependence; 21-60: Severe dependence; 61-90: Moderate dependence; 91-99: Low dependence; 100: Independence
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Barthel Index
Obtained
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Barthel Index
Total dependence
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Barthel Index
Severe dependence
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Barthel Index
Moderate dependence
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Barthel Index
Low dependence
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Barthel Index
Independence
|
9 Participants
|
14 Participants
|
11 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.Percentage of patients requiring hospital readmission
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
Patients Requiring Hospital Readmission
Post-COVID-19 complications
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patients Requiring Hospital Readmission
COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patients Requiring Hospital Readmission
No COVID-19 related
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Patients Requiring Hospital Readmission
No readmission
|
9 Participants
|
13 Participants
|
11 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.minute walking test mean, standard deviation. Total distance measured in meters (m)
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
6 Minute Walking Test (Total Distance)
|
486.4 m
Standard Deviation 115.8
|
453.9 m
Standard Deviation 77.7
|
445.1 m
Standard Deviation 134.0
|
459.7 m
Standard Deviation 106.5
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.minute walking test mean, standard deviation. Expected distance (the predicted distance that a patient could walk) measured in meters (m)
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
6 Minute Walking Test (Expected Distance)
|
806.7 m
Standard Deviation 101.7
|
853.5 m
Standard Deviation 149.7
|
818.7 m
Standard Deviation 101.9
|
829.8 m
Standard Deviation 122.1
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.6 minute walking test mean, standard deviation. Unit of measure: Percentage of predicted distance
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
6 Minute Walking Test (Percentage of Predicted Distance)
|
61.4 Percentage of predicted distance
Standard Deviation 16.8
|
54.3 Percentage of predicted distance
Standard Deviation 11.9
|
54.6 Percentage of predicted distance
Standard Deviation 16.6
|
56.3 Percentage of predicted distance
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: At study inclusion, an average of 12 months after end of APLICOV-PC study.6 minute walking test mean, standard deviation. Unit of measure: Number of laps of 60 m
Outcome measures
| Measure |
Arm A: Experimental 1
n=9 Participants
1.5 mg of plitidepsin / day
|
Arm B: Experimental 2
n=14 Participants
2.0 mg of plitidepsin / day
|
Arm C: Experimental 3
n=11 Participants
2.5 mg of plitidepsin / day
|
Total
n=34 Participants
|
|---|---|---|---|---|
|
6 Minute Walking Test (Number of Laps of 60 m)
|
22.8 Number of laps of 60 m
Standard Deviation 14.7
|
14.0 Number of laps of 60 m
Standard Deviation 7.2
|
15.7 Number of laps of 60 m
Standard Deviation 12.5
|
16.9 Number of laps of 60 m
Standard Deviation 11.6
|
Adverse Events
Arm A: Experimental 1
Arm B: Experimental 2
Arm C: Experimental 3
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Development Virology Business Unit PharmaMar
PharmaMar, S.A.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60