Phase 2
N=34
Extension Study in a Cohort of Adult Patients With COVID-19 Infection
COVID-19 Infection
Bottom Line
View on ClinicalTrials.gov: NCT05121740 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number and Percentage of Participants With Complications Related to Post COVID-19 Infection — 4; 8; 5; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Plitidepsin 1.5 mg / day (Drug); Plitidepsin 2.0 mg / day (Drug); Plitidepsin 2.5 mg / day (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- PharmaMar
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants With Complications Related to Post COVID-19 Infection |
4; 8; 5; 17 | — |
| SECONDARY Patients Requiring Oxygen Therapy |
1; 2; 0; 3 | — |
| SECONDARY Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). |
1; 2; 5; 8; 8; 12 | — |
| SECONDARY Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2) |
472.0; 464.2; 518.7; 482.8 | — |
| SECONDARY Forced Expiratory Volume 1 (FEV1) |
3052; 3267; 2857; 3078 | — |
| SECONDARY Lung Diffusion Testing |
98.4; 100.1; 105.2; 101.3 | — |
| SECONDARY Patients With Alterations in Chest Radiography |
0; 0; 0; 0 | — |
| SECONDARY Patients With Electrocardiogram Alterations |
1; 3; 1; 5 | — |
| SECONDARY Patients With ≥Grade 2 Alterations in Laboratory Parameters |
1; 1; 1; 3 | — |
| SECONDARY Modified Medical Research Council (mMRC) Dyspnea Scale |
5; 7; 9; 21; 2; 6 | — |
| SECONDARY FEV1/FVC |
79.9; 79.3; 78.1; 79.1 | — |
| SECONDARY Forced Vital Capacity (FVC) |
3809; 4107; 3751; 3913 | — |
| SECONDARY Arterial Oxygen Saturation (SaO2) |
97.2; 97.1; 98.1; 97.4 | — |
| SECONDARY Barthel Index |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Patients Requiring Hospital Readmission |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 6 Minute Walking Test (Total Distance) |
486.4; 453.9; 445.1; 459.7 | — |
| SECONDARY 6 Minute Walking Test (Expected Distance) |
806.7; 853.5; 818.7; 829.8 | — |
| SECONDARY 6 Minute Walking Test (Percentage of Predicted Distance) |
61.4; 54.3; 54.6; 56.3 | — |
| SECONDARY 6 Minute Walking Test (Number of Laps of 60 m) |
22.8; 14.0; 15.7; 16.9 | — |
Summary
The main objective of this study is to evaluate the incidence of post-COVID morbidity and characterize the complications profile in patients who participated in the APLICOV-PC study. APLICOV-PC study was a multicenter, randomized, proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin (1,5 mg, 2,0 mg and 2,5 mg) administered three consecutive days, in adult patients with confirmed diagnosis of COVID-19 who require hospital admission.
Eligibility Criteria
Inclusion Criteria
- Patient who participated in the APLICOV-PC study receiving treatment with plitidepsin and who gives consent.
Exclusion Criteria
- There are no exclusion criteria for this study.
Data sourced from ClinicalTrials.gov (NCT05121740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.