Safety and Efficacy of Convalescent Plasma in Elderly COVID-19 Patients: The RESCUE Trial

Massimo Franchini, Claudia Glingani, Mario Morandi, Giovanni Corghi, Sara Cerzosimo, Gloria Beduzzi, Andrea Storti, Vincenza Di Stasi, Giulia Rastrelli, Linda Vignozzi, Carlo Mengoli, Martina Garuti, Massimiliano Beccaria, Francesco Inglese, Beatrice Caruso, Roberto Antonio Petilino, Massimo Amato, Michele Nicchio, Mauro Pagani, Angela Bellani, Gianpaolo Castelli, Salvatore Casari, Giuseppe De Donno, Massimo Franchini, Claudia Glingani, Mario Morandi, Giovanni Corghi, Sara Cerzosimo, Gloria Beduzzi, Andrea Storti, Vincenza Di Stasi, Giulia Rastrelli, Linda Vignozzi, Carlo Mengoli, Martina Garuti, Massimiliano Beccaria, Francesco Inglese, Beatrice Caruso, Roberto Antonio Petilino, Massimo Amato, Michele Nicchio, Mauro Pagani, Angela Bellani, Gianpaolo Castelli, Salvatore Casari, Giuseppe De Donno

Abstract

Objective: To assess the safety and efficacy of convalescent plasma (CP) transfusion in elderly people with moderate to severe coronavirus disease 2019 (COVID-19) living in a long-term care facility (LTCF).

Patients and methods: Twenty-two consecutive elderly patients with COVID-19 infection living in an LTCF in Lombardy, Italy, who were given CP during May 15 to July 31, 2020, were enrolled in a prospective cohort study. Their clinical, instrumental, and laboratory parameters were assessed following the CP treatment. The overall mortality rate in this group was compared with that recorded in other LTCFs in Lombardy during the 3-month period from March to May 2020.

Results: Of the 22 patients enrolled, 68.2% (n=15) received 1 CP unit, 27.3% (n=6) received 2 units, and 4.5% (n=1) received 3 units. Of the CP units transfused, 76.7% (23/30) had a neutralizing antibody titer of 1:160 or greater. No adverse reactions were recorded during or after CP administration. Improvements in clinical, functional, radiologic, and laboratory parameters during the 14 days after CP transfusion were observed in all 19 patients who survived. Viral clearance was achieved in all patients by the end of follow-up (median, 66 days; interquartile range, 48-80 days). The overall mortality rate was 13.6% (3/22), which compared favorably with that in the control group (38.3% [281/733]; P=.02) and corresponded to a 65% reduction in mortality risk.

Conclusion: Early administration of CP with an adequate anti-severe acute respiratory syndrome coronavirus 2 antibody titer to elderly symptomatic patients with COVID-19 infection in an LTCF was safe and effective in eliminating the virus, restoring patients' immunity, and blocking the progression of COVID-19 infection, thereby improving patients' survival.

Trial registration: ClinicalTrials.gov: NCT04569188.

Keywords: COVID-19, coronavirus disease 2019; CP, convalescent plasma; CRP, C-reactive protein; Fio2, fraction of inspired oxygen; IL-6, interleukin 6; IQR, interquartile range; ISS, Italian National Institute of Health; LTCF, long-term care facility; NNT, number needed to treat; NS, not significant; PCR, polymerase chain reaction; RESCUE, Real-time Evaluation of Safety and Efficacy of Convalescent Plasma Units Transfused to Elderly Patients With COVID-19; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

© 2021 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc.

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Source: PubMed

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