NEREIDA
Research type
Research Study
Full title
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 (NEREIDA)
IRAS ID
1006650
Contact name
Luis Mora Capitan
Contact email
Sponsor organisation
Pharma Mar, S.A.
Eudract number
2022-002489-34
Research summary
This study will test the Efficacy and Safety of Plitidepsin versus Control in Immunocompromised Adult Patients with Symptomatic COVID-19 requiring Hospital Care. Immunocompromised patients are at increased risk for severe and fatal COVID 2019 outcomes. Of additional concern is the widespread use of immunosuppressive medications to treat COVID-19. The RECOVERY trial, which showed a significant reduction in mortality among patients with COVID-19 who received dexamethasone, resulted in a paradigm shift in the medical management of COVID-19, whereby immunomodulation and not antiviral therapy has become an accepted clinical practice standard. Given that immunosuppressed patients are at risk for protracted SARS-CoV-2 infection, concerns have been raised about whether immunosuppressive therapies may promote chronic infection and worse outcomes, including selection and transmission of new SARS-CoV-2 variants. Thus, studies among immunocompromised hosts should be focused on identifying direct acting antivirals that markedly reduce SARS-CoV-2 replication. In preclinical studies, plitidepsin showed strong antiviral activity in in vitro models of SARS-CoV-2 infection, also showing a better therapeutic index than other drugs used in the treatment of SARS-CoV-2, including remdesivir.
The study will include a Screening period, a Treatment period and a Follow-up period lasting, in total approximately 60 days for each participant. All participants will receive the best available supportive care as per applicable local and national COVID-19 treatment guidelines. Participants assigned to the experimental arms will receive, in addition, plitidepsin as a 1-h IV infusion, during days 1 to 3. At the end of the study participants will take part in an end of study visit. Full details of the participant procedures can be found on pages 63 to 75 of the study protocol. The first 30 participants will additionally take part in a PK sub study detailed on page 88 of the study protocol.
REC name
London - South East Research Ethics Committee
REC reference
23/LO/0103
Date of REC Opinion
7 Sep 2023
REC opinion
Further Information Favourable Opinion