Extension Study in a Cohort of Adult Patients With COVID-19 Infection

NCT05121740 | Completed Phase 1 Results

• 2 other identifiers: AV-APL-A-003-212021-004966-37
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

COVID-19 Infection

Keywords

Plitidepsin; COVID-19; Post-COVID morbidity

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Participants With Complications Related to Post COVID-19 Infection

  Number and percentage of patients who developed complications related to post COVID-19 infection

  Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.

Secondary Outcomes (18)

• Patients Requiring Oxygen Therapy

  Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.

• Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not).

  Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months..

• Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2)

  At study inclusion, an average of 12 months after end of APLICOV-PC study.

• Forced Expiratory Volume 1 (FEV1)

  At study inclusion, an average of 12 months after end of APLICOV-PC study.

• Lung Diffusion Testing

  At study inclusion, an average of 12 months after end of APLICOV-PC study.

Study Arms (3)

Arm A: Experimental 1

EXPERIMENTAL

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).

Drug: Plitidepsin 1.5 mg / day

Arm B: Experimental 2

EXPERIMENTAL

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).

Drug: Plitidepsin 2.0 mg / day

Arm C: Experimental 3

EXPERIMENTAL

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).

Drug: Plitidepsin 2.5 mg / day

Interventions

Plitidepsin 1.5 mg / day DRUG

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 A: Experimental 1

Plitidepsin 2.0 mg / day DRUG

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 B: Experimental 2

Plitidepsin 2.5 mg / day DRUG

Plitidepsin 2.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 7.5 mg).

Arm C: Experimental 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who participated in the APLICOV-PC study receiving treatment with plitidepsin and who gives consent.

Sponsors & Collaborators

• PharmaMar: lead
• Apices Soluciones S.L.: collaborator

Study Sites (10)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario HM Montepríncipe

Boadilla del Monte, Madrid, 28660, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital General de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario de Getafe

Getafe, 280989, Spain

Location

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 280029, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Universitario La Princesa

Madrid, 280127, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 36909731 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

COVID-19

Interventions

plitidepsin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Low sample size and a lack of control group.

Results Point of Contact

• Title: Clinical Development Virology Business Unit PharmaMar
• Organization: PharmaMar, S.A.

virologytrials@pharmamar.com; clinicaltrials@pharmamar.com

91 846 60 00

Study Officials

• José Felipe Varona, MD

  Hospital Universitario HM Montepríncipe

  PRINCIPAL INVESTIGATOR

• Pedro Landete, MD

  Hospital Universitario La Princesa

  PRINCIPAL INVESTIGATOR

• Pablo Guisado-Vasco, MD

  Quironsalud

  PRINCIPAL INVESTIGATOR

• Roger Paredes, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Follow up Multicentric extension study of APLICOV-PC clinical trial.

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 16, 2021
• Study Start: January 25, 2022
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: December 31, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-12

Locations

ES (10)