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

NCT05121740 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-12-31

Study results available
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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

Interventions

DRUG

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).

DRUG

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).

DRUG

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).

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • PharmaMar

    lead INDUSTRY

Principal Investigators

  • José Felipe Varona, MD · Hospital Universitario HM Montepríncipe

  • Pedro Landete, MD · Hospital Universitario La Princesa

  • Pablo Guisado-Vasco, MD · Quironsalud

  • Roger Paredes, MD · Germans Trias i Pujol Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2022-03-16
Completion
2022-03-16

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05121740 on ClinicalTrials.gov