Phase I dose-escalation single centre clinical trial to evaluate the safety of infusion of memory T cells as adoptive therapy in COVID-19 (RELEASE).

BACKGROUND

Effective treatments are still needed to reduce the severity of symptoms, time of hospitalization, and mortality of COVID-19. SARS-CoV-2 specific memory T-lymphocytes obtained from convalescent donors recovered can be used as passive cell immunotherapy.

METHODS

Between September and November 2020 a phase 1, dose-escalation, single centre clinical trial was conducted to evaluate the safety and feasibility of the infusion of CD45RA

FINDINGS

All participants' clinical status measured by National Early Warning Score (NEWS) and 7-category point ordinal scales showed improvement six days after infusion. No serious adverse events were reported. Inflammatory parameters were stabilised post-infusion and the participants showed lymphocyte recovery two weeks after the procedure. Donor microchimerism was observed at least for three weeks after infusion in all patients.

INTERPRETATION

This study provides preliminary evidence supporting the idea that treatment of COVID-19 patients with moderate/severe symptoms using convalescent CD45RA

FUNDING

Clinical Trial supported by Spanish Clinical Research Network PT17/0017/0013. Co-funded by European Regional Development Fund/European Social Fund. CRIS CANCER Foundation Grant to AP-M and Agencia Valenciana de Innovación Grant AVI-GVA COVID-19-68 to BS.

Informations de copyright

© 2021 The Author(s).

Déclaration de conflit d'intérêts

AP-M filed patent EP20382850 on Memory T cells as adoptive cell therapy for viral diseases. CF filed patent EP20382850 on Memory T cells as adoptive cell therapy for viral diseases. BS received salary from University Miguel Hernandez, a grant from Agencia Valenciana de Innovacion, support from Al-Andalus Biopharma and medical writing from Comunidad de Madrid, since the initial planning of the work. He received grant AVI-GVA CO19–068 and consulting fees from Gilead-Weber. BS is on the board at Institut de Bioengineria de Catalunya and Laminar Pharmaceuticals. BS filed patent EP20382850 on Memory T cells as adoptive cell therapy for viral diseases. BS reports an unpaid role with FAID. BS reports the receipt of equipment, materials, drugs, medical writing, gifts or other services from Al-Andalus BioPharmaSL. CS received fees from MSD, Pfizer and Gilead not related to this topic, and reports payments made by Gilead, MSD, Janssen and Therakos to suppliers for support for attending meetings and/or travel. IG reports a “Rio Hortega” Grant (Plan Estatal de I + D + I 2013–2016. Plan Estatal de Investigación Científica y Técnica y de Innovación (2017–2020). Co-funded by European Regional Development Fund/European Social Fund "A way to make Europe"/"Investing in your future"). All other authors have nothing to declare.