Convalescent plasma in COVID-19. Mortality-safety first results of the prospective multicenter FALP 001-2020 trial

dc.catalogadoraba
dc.contributor.authorGazitúa, R.
dc.contributor.authorBriones, J. L.
dc.contributor.authorSelman, C.
dc.contributor.authorVillarroel Espíndola, F.
dc.contributor.authorAguirre, A.
dc.contributor.authorGonzález Steigmaier, R.
dc.contributor.authorCereceda, K.
dc.contributor.authorMahave, M.
dc.contributor.authorRubio, B.
dc.contributor.authorFerrer Rosende, P.
dc.contributor.authorSapunar, J.
dc.contributor.authorMarsiglia, H.
dc.contributor.authorMorales, R.
dc.contributor.authorYarad, F.
dc.contributor.authorBalcells Marty, María Elvira
dc.contributor.authorRojas, Luis
dc.contributor.authorNervi Nattero, Bruno
dc.contributor.authorNien, J. K.
dc.contributor.authorGarate, J.
dc.contributor.authorPrieto, C.
dc.contributor.authorPalma, S.
dc.contributor.authorEscobar, C.
dc.contributor.authorBascuñan, J.
dc.contributor.authorMuñoz, R.
dc.contributor.authorPinto, M.
dc.contributor.authorCardemil, D.
dc.contributor.authorNavarrete, M.
dc.contributor.authorReyes, S.
dc.contributor.authorEspinosa, V.
dc.contributor.authorYáñez, N.
dc.contributor.authorCaglevic, C.
dc.date.accessioned2023-11-10T19:19:23Z
dc.date.available2023-11-10T19:19:23Z
dc.date.issued2020
dc.descriptionBackground The use of convalescent plasma (CP) to treat COVID-19 has shown promising results; however, its effectiveness remains uncertain. The purpose of this study was to determine the safety and mortality of CP among patients hospitalized with COVID-19. Study Design and Methods This multicenter, open-label, uncontrolled clinical trial is currently being conducted at nine hospitals in Chile. Patients hospitalized due to COVID-19 who were still within 14 days since symptom onset were classified into four groups: Patients with cancer and severe COVID-19. Patients with cancer and non-severe COVID-19. Patients with severe COVID-19 and patients with non-severe COVID-19 only. The intervention involved two 200-cc. CP transfusions with anti-SARS-CoV-2 IgG titers ≥ 1:320 collected from COVID-19-recovered donors. Results 192 patients hospitalized for COVID-19 received CP transfusions. At the first transfusion, 90.6% fulfilled the criteria for severity, and 41.1% required mechanical ventilation. 11.5% of the patients had cancer. Overall 7-day and 30-day mortality since the first CP transfusion was 5.7% and 16.1% respectively. There were no differences at either time point in mortality between the four groups. Patients on mechanical ventilation when receiving CP had higher mortality rates than those who were not (22.8% vs. 11.5%; p = 0.037). Overall 30-day mortality was higher in patients over 65 than in younger patients (p = 0.019). Severe adverse events were reported in four patients (2.1%) with an overall transfusion-related lung injury rate of 1.56%. No CP-related deaths occurred. Discussion CP is safe when used in patients with COVID-19 even when also presenting severity criteria or risk factors. Our mortality rate is comparable to reports from larger studies. Controlled clinical trials are required to determine efficacy.
dc.fechaingreso.objetodigital2023-11-10
dc.fuente.origenORCID
dc.identifier.doi10.1101/2020.11.30.20218560
dc.identifier.urihttps://doi.org/10.1101/2020.11.30.20218560
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/75294
dc.information.autorucEscuela de Medicina; Balcells Marty, Maria Elvira; 0000-0002-7223-9665; 7462
dc.information.autorucEscuela de Medicina; Nervi Nattero, Bruno; 0000-0002-3016-7261; 604
dc.language.isoen
dc.nota.accesoContenido completo
dc.pagina.final27
dc.pagina.inicio1
dc.revistamedRxiv. The prerint server for health science
dc.rightsacceso abierto
dc.rights.licenseCC-BY-NC-ND 4.0 International license
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subjectCOVID-19
dc.subjectConvalescent Plasma
dc.subjectSARS- COV2
dc.subjectLung Infectious Diseases
dc.subjectCancer
dc.subject.ddc610
dc.subject.deweyMedicina y saludes_ES
dc.titleConvalescent plasma in COVID-19. Mortality-safety first results of the prospective multicenter FALP 001-2020 trial
dc.typepreprint
sipa.codpersvinculados7462
sipa.codpersvinculados604
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