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