Extension Study in a Cohort of Adult Patients With COVID-19 Infection
NCT ID: NCT05121740
Last Updated: 2024-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2022-01-25
2022-03-16
Brief Summary
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Detailed Description
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A percentage of patients, which varies between 10 and 25%, continue to show symptoms at 3 months after contracting the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: For some of them this significantly restricts their life, requiring them to take long-term sickness leave from work, and leaving them with sequelae that may continue for more than one year.
With this study, Pharmamar intends to evaluate whether the treatment with plitidepsin, by attaining a reduction in the viral load and a faster recovery of the patient, could have a relevant impact on the emergence of sequelae resulting from the SARS-CoV-2 infection.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A: Experimental 1
In the APLICOV-PC study, patients of arm A received 1.5 mg of plitidepsin / day for 3 consecutive days (total dose 4.5 mg).
Plitidepsin 1.5 mg / day
Plitidepsin 1.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 4.5 mg).
Arm B: Experimental 2
In the APLICOV-PC study, patients of arm B received 2.0 mg of plitidepsin / day for 3 consecutive days (total dose 6.0 mg).
Plitidepsin 2.0 mg / day
Plitidepsin 2.0 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 6.0 mg).
Arm C: Experimental 3
In the APLICOV-PC study, patients of arm C received 2.5 mg of plitidepsin / day for 3 consecutive days (total dose 7.5 mg).
Plitidepsin 2.5 mg / day
Plitidepsin 2.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 7.5 mg).
Interventions
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Plitidepsin 1.5 mg / day
Plitidepsin 1.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 4.5 mg).
Plitidepsin 2.0 mg / day
Plitidepsin 2.0 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 6.0 mg).
Plitidepsin 2.5 mg / day
Plitidepsin 2.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 7.5 mg).
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Apices Soluciones S.L.
INDUSTRY
PharmaMar
INDUSTRY
Responsible Party
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Principal Investigators
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José Felipe Varona, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario HM Montepríncipe
Pedro Landete, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Princesa
Pablo Guisado-Vasco, MD
Role: PRINCIPAL_INVESTIGATOR
Quironsalud
Roger Paredes, MD
Role: PRINCIPAL_INVESTIGATOR
Germans Trias i Pujol Hospital
Locations
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Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario HM Montepríncipe
Boadilla del Monte, Madrid, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital General de Ciudad Real
Ciudad Real, , Spain
Hospital Universitario de Getafe
Getafe, , Spain
Hospital Universitario de Guadalajara
Guadalajara, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Countries
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References
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Varona JF, Landete P, Paredes R, Vates R, Torralba M, Guisado-Vasco P, Porras L, Munoz P, Gijon P, Ancochea J, Saiz E, Meira F, Jimeno JM, Lopez-Martin JA, Estrada V. Plitidepsin in adult patients with COVID-19 requiring hospital admission: A long-term follow-up analysis. Front Cell Infect Microbiol. 2023 Feb 22;13:1097809. doi: 10.3389/fcimb.2023.1097809. eCollection 2023.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2021-004966-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AV-APL-A-003-21
Identifier Type: -
Identifier Source: org_study_id