Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial
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...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-05-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/11/11/3039 |
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| author | Joan Bargay-Lleonart Fiorella Sarubbo Maria Arrizabalaga José Maria Guerra Josep Borràs Khaoulah El Haji Magdalena Flexas Jorge Perales Victoria Fernández-Baca Carmen Gallegos Manuel Raya Cruz Sonia Velasco Víctor López Ana Cruz Antonia Bautista-Gili Teresa Jimenez-Marco Enric Girona-Llobera Laia Vilaplana Laura Calonge Juan Tena Maria Pilar Galán Antoni Payeras |
| author_facet | Joan Bargay-Lleonart Fiorella Sarubbo Maria Arrizabalaga José Maria Guerra Josep Borràs Khaoulah El Haji Magdalena Flexas Jorge Perales Victoria Fernández-Baca Carmen Gallegos Manuel Raya Cruz Sonia Velasco Víctor López Ana Cruz Antonia Bautista-Gili Teresa Jimenez-Marco Enric Girona-Llobera Laia Vilaplana Laura Calonge Juan Tena Maria Pilar Galán Antoni Payeras |
| author_sort | Joan Bargay-Lleonart |
| collection | DOAJ |
| description | 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) (<i>n</i> = 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) (<i>n</i> = 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. |
| first_indexed | 2024-03-10T01:12:08Z |
| format | Article |
| id | doaj.art-57acd6ec6a6e4f2b861ac1a55379c274 |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-10T01:12:08Z |
| publishDate | 2022-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-57acd6ec6a6e4f2b861ac1a55379c2742023-11-23T14:15:47ZengMDPI AGJournal of Clinical Medicine2077-03832022-05-011111303910.3390/jcm11113039Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical TrialJoan Bargay-Lleonart0Fiorella Sarubbo1Maria Arrizabalaga2José Maria Guerra3Josep Borràs4Khaoulah El Haji5Magdalena Flexas6Jorge Perales7Victoria Fernández-Baca8Carmen Gallegos9Manuel Raya Cruz10Sonia Velasco11Víctor López12Ana Cruz13Antonia Bautista-Gili14Teresa Jimenez-Marco15Enric Girona-Llobera16Laia Vilaplana17Laura Calonge18Juan Tena19Maria Pilar Galán20Antoni Payeras21Hematology Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainFaculty of Medicine, University of the Balearic Islands, 07122 Palma, SpainInternal Medicine Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainHematology Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainHematology Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainHealth Research Institute of the Balearic Islands (IdISBa), 07198 Palma, SpainHematology Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainHematology Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainMicrobiology Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainMicrobiology Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainInternal Medicine Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainHematology Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainHematology Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainInternal Medicine Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainBlood and Tissue Bank Foundation of the Balearic Islands (FBSTIB), Cr. Rosselló i Cazador, 20, 07004 Palma, SpainBlood and Tissue Bank Foundation of the Balearic Islands (FBSTIB), Cr. Rosselló i Cazador, 20, 07004 Palma, SpainBlood and Tissue Bank Foundation of the Balearic Islands (FBSTIB), Cr. Rosselló i Cazador, 20, 07004 Palma, SpainInternal Medicine Department, Hospital Comarcal Manacor, Crta. Manacor Alcudia, 07500 Manacor, SpainInternal Medicine Department, Mateu Orfila Hospital, Menorca, Rda. de Malbúger, 1, 07703 Mahón, SpainHematology Department, Mateu Orfila Hospital, Menorca, Rda. de Malbúger, 1, 07703 Mahón, SpainHematology Department, Mateu Orfila Hospital, Menorca, Rda. de Malbúger, 1, 07703 Mahón, SpainInternal Medicine Department, Son Llàtzer University Hospital, Crta. Manacor Km 4, 07198 Palma, SpainBackground: 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) (<i>n</i> = 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) (<i>n</i> = 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.https://www.mdpi.com/2077-0383/11/11/3039COVID-19hyperimmune plasmaconvalescent plasmadonorsantibodyrandomized clinical trial |
| spellingShingle | Joan Bargay-Lleonart Fiorella Sarubbo Maria Arrizabalaga José Maria Guerra Josep Borràs Khaoulah El Haji Magdalena Flexas Jorge Perales Victoria Fernández-Baca Carmen Gallegos Manuel Raya Cruz Sonia Velasco Víctor López Ana Cruz Antonia Bautista-Gili Teresa Jimenez-Marco Enric Girona-Llobera Laia Vilaplana Laura Calonge Juan Tena Maria Pilar Galán Antoni Payeras Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial Journal of Clinical Medicine COVID-19 hyperimmune plasma convalescent plasma donors antibody randomized clinical trial |
| title | Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial |
| title_full | Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial |
| title_fullStr | Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial |
| title_full_unstemmed | Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial |
| title_short | Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial |
| title_sort | reinforcement of the standard therapy with two infusions of convalescent plasma for patients with covid 19 a randomized clinical trial |
| topic | COVID-19 hyperimmune plasma convalescent plasma donors antibody randomized clinical trial |
| url | https://www.mdpi.com/2077-0383/11/11/3039 |
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