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Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care (NEREIDA) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care (NEREIDA)

A Multicentre, Open Label, Randomised, Controlled, Basket, Pragmatic, Phase II, Clinical and Translational Study to Determine the Efficacy and Safety of Plitidepsin Versus Control in Immunocompromised Adult Patients With Symptomatic COVID-19 Requiring Hospital Care

NCT05705167•PharmaMar

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate efficacy of plitidepsin in pre-specified groups of immunocompromised patients with symptomatic COVID-19 requiring hospital care versus control in terms of mortality.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent obtained prior to initiation of any study-specific procedures and study treatment.
•Participant aged ≥18 years.
•Participant diagnosed COVID-19, with the following characteristics:
•1. A regulatory-approved test, collected no more than 3 days prior to study randomisation, with either a Ct value ≤30 or a positive antigen test.
•2. Presence of any of the selected signs/symptom listed in the COVID-19 signs/symptoms checklist within the last 24 hours.
•Participant already admitted or requiring hospital care for symptomatic COVID-19, for which at least one antiviral has failed or cannot be used (i.e., contraindication, absence of labelled indication, guidelines or drug unavailability), after a minimum washout period of 24 hours for small molecules (e.g., remdesivir, molnupiravir, nirmaltrevir, ritonavir) and 5 days for antiviral monoclonal antibodies (e.g., tixagevimab + cilgavimab) or convalescent plasma.
•Adequate bone marrow, liver, kidney, and metabolic function, defined by the following tests performed at local laboratory:
•1. Absolute neutrophil count ≥500/mm\^3 (0.5 x 109/L).
•2. Platelet count ≥ 50 000/mm3 (50 x 109/L).
•3. Alanine transaminase (ALT) ≤3 x upper limit of normal (ULN) (≤5 x ULN if preexistent liver involvement by the underlying disease).
+13 more criteria

Exclusion Criteria

•Evidence of critical illness.
•Any of the following cardiac conditions or risk factors:
•1. Cardiac infarction or cardiac surgery episode within the last month.
•2. History of known congenital QT prolongation.
•3. Known structural cardiomyopathy with abnormal left ventricular ejection fraction (LVEF) (\<50%).
•4. Current clinical evidence of heart failure or acute cardiac ischaemia (New York Heart Association (NYHA) class III-IV).
•Hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) or contraindication to receive dexamethasone, antihistamine H1/H2, or anti-serotoninergic 5HT3 agents.
•Females who are pregnant or breast-feeding.
•Females and males with partners of child-bearing potential who are not using at least 1 protocol-specified method of contraception.
•Any situation currently requiring increasing needs of immune-suppressive agents.
+2 more criteria

Locations (44)

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Flemish Brabant, Belgium

Cancer Research Centre of Lyon

Lyon, Auvergne-Rhône-Alpes, France

Hôpitaux Civils de Colmar - Centre Hospitalier Louis Pasteur

Colmar, Grand Est, France

Centre Hospitalier Régional Universitaire de Tours

Tours, Indre-et-Loire, France

Centre Hospitalier de la Côte Basque

Bayonne, Pyrénées-Atlantiques, France

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, France

The First University Clinic of the Tbilisi State Medical University

Tbilisi, Georgia

Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, Georgia

Academician Vakhtang Bochorishvili Clinic

Tbilisi, Georgia

General Hospital of Athens Evangelismos

Athens, Attica, Greece

Key Dates

Start Date

April 19, 2023

Primary Completion Date

March 19, 2024

Completion Date

April 19, 2024

Last Updated

December 2, 2024

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

Plitidepsin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care (NEREIDA)

Inclusion Criteria

Exclusion Criteria

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