J Clin Med . Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial

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J Clin Med


. 2022 May 27;11(11):3039.
doi: 10.3390/jcm11113039.
Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial


Joan Bargay-Lleonart ^{1 2 3 4} , Fiorella Sarubbo ^{2 4 5 6} , Maria Arrizabalaga ⁷ , José Maria Guerra ^{1 3 4} , Josep Borràs ^{1 3 4} , Khaoulah El Haji ^{4 5} , Magdalena Flexas ^{1 3 4} , Jorge Perales ^{1 3 4} , Victoria Fernández-Baca ^{8 9} , Carmen Gallegos ^{8 10} , Manuel Raya Cruz ⁷ , Sonia Velasco ¹ , Víctor López ¹ , Ana Cruz ⁷ , Antonia Bautista-Gili ^{11 12} , Teresa Jimenez-Marco ^{11 12} , Enric Girona-Llobera ^{11 12} , Laia Vilaplana ¹³ , Laura Calonge ¹⁴ , Juan Tena ¹⁵ , Maria Pilar Galán ¹⁵ , Antoni Payeras ^{7 10}



Affiliations

• PMID: 35683427
• DOI: 10.3390/jcm11113039

Abstract

Background: The aim was to evaluate the reinforcement of the standard therapy with hyperimmune plasma (HP) in Coronavirus-19 disease (COVID-19) patients.
Methods: Open-label, multicenter, randomized clinical trial performed in three hospitals in the Balearic Islands. Non-severe COVID-19 hospitalized patients with clinical time evolution equal to/less than 7 days were included, and randomized in: plasma group (PG) (n = 37), receiving 600 mL divided into two doses from convalescent plasma donor, administered on days 1 and 2 after the enrollment; and control group (CG) (n = 17). Primary outcome was the time for clinical improvement within 21 days, defined as patient achievement of categories 8, 7, and 6 in the Adaptive COVID-19 Treatment Trial scale (ACTT). The trial was terminated early due to the impossibility of recruitment due to the pandemic.
Results: PG presented better scores on the ACTT scale at 7 days after HP infusion, whereas CG was needed 14 days to achieve similar results. The plasma infusion was safe.
Conclusions: Despite the tendency observed in the plasma group to achieve slightly earlier better physical condition compared with the standard treatment alone. The administration of HP has been shown to be a safe therapy. No robust evidence was found to affirm a therapeutic effect of the early administration of two infusions of HP for non-severe COVID-19 infected patients. The interpretation is limited by the early termination of the trial, which resulted in a small sample size.

Keywords: COVID-19; antibody; convalescent plasma; donors; hyperimmune plasma; randomized clinical trial.