Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial

  1. BALCELLS, María Elvira ORCID logo
  2. rojas, luis ORCID logo
  3. Le Corre, Nicole ORCID logo
  4. Martinez-Valdebenito, Constanza ORCID logo
  5. Ceballos, Maria Elena ORCID logo
  6. Ferrés, Marcela
  7. Chang, Mayling
  8. Vizcaya, Cecilia
  9. Mondaca, Sebastián
  10. Huete, Alvaro ORCID logo
  11. Castro, Ricardo ORCID logo
  12. sarmiento m, mauricio ORCID logo
  13. Villarroel, Luis ORCID logo
  14. Pizarro, Alejandra
  15. Ross, Patricio ORCID logo
  16. Santander, Jaime ORCID logo
  17. Lara, Barbara ORCID logo
  18. Ferrada, Marcela
  19. Vargas-Salas, Sergio ORCID logo
  20. Beltrán-Pavez, Carolina
  21. Soto Rifo, Ricardo ORCID logo
  22. Valiente-Echeverría, Fernando
  23. Caglevic, Christian
  24. Mahave, Mauricio
  25. Selman, Carolina
  26. gazitua, raimundo ORCID logo
  27. BRIONES MARTINEZ, JOSE LUIS ORCID logo
  28. Villarroel-Espindola, Franz
  29. Balmaceda, Carlos
  30. Espinoza, Manuel ORCID logo
  31. Pereira, Jaime
  32. Nervi, Bruno

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WeightNameValue
1000 Titel
  • Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial
1000 Autor/in
  1. BALCELLS, María Elvira |
  2. rojas, luis |
  3. Le Corre, Nicole |
  4. Martinez-Valdebenito, Constanza |
  5. Ceballos, Maria Elena |
  6. Ferrés, Marcela |
  7. Chang, Mayling |
  8. Vizcaya, Cecilia |
  9. Mondaca, Sebastián |
  10. Huete, Alvaro |
  11. Castro, Ricardo |
  12. sarmiento m, mauricio |
  13. Villarroel, Luis |
  14. Pizarro, Alejandra |
  15. Ross, Patricio |
  16. Santander, Jaime |
  17. Lara, Barbara |
  18. Ferrada, Marcela |
  19. Vargas-Salas, Sergio |
  20. Beltrán-Pavez, Carolina |
  21. Soto Rifo, Ricardo |
  22. Valiente-Echeverría, Fernando |
  23. Caglevic, Christian |
  24. Mahave, Mauricio |
  25. Selman, Carolina |
  26. gazitua, raimundo |
  27. BRIONES MARTINEZ, JOSE LUIS |
  28. Villarroel-Espindola, Franz |
  29. Balmaceda, Carlos |
  30. Espinoza, Manuel |
  31. Pereira, Jaime |
  32. Nervi, Bruno |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-03-03
1000 Erschienen in
1000 Quellenangabe
  • 18(3):e1003415
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1371/journal.pmed.1003415 |
1000 Ergänzendes Material
  • https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003415#sec026 |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • BACKGROUND: Convalescent plasma (CP), despite limited evidence on its efficacy, is being widely used as a compassionate therapy for hospitalized patients with COVID-19. We aimed to evaluate the efficacy and safety of early CP therapy in COVID-19 progression. METHODS AND FINDINGS: The study was an open-label, single-center randomized clinical trial performed in an academic medical center in Santiago, Chile, from May 10, 2020, to July 18, 2020, with final follow-up until August 17, 2020. The trial included patients hospitalized within the first 7 days of COVID-19 symptom onset, presenting risk factors for illness progression and not on mechanical ventilation. The intervention consisted of immediate CP (early plasma group) versus no CP unless developing prespecified criteria of deterioration (deferred plasma group). Additional standard treatment was allowed in both arms. The primary outcome was a composite of mechanical ventilation, hospitalization for >14 days, or death. The key secondary outcomes included time to respiratory failure, days of mechanical ventilation, hospital length of stay, mortality at 30 days, and SARS-CoV-2 real-time PCR clearance rate. Of 58 randomized patients (mean age, 65.8 years; 50% male), 57 (98.3%) completed the trial. A total of 13 (43.3%) participants from the deferred group received plasma based on clinical aggravation. We failed to find benefit in the primary outcome (32.1% versus 33.3%, odds ratio [OR] 0.95, 95% CI 0.32–2.84, p > 0.999) in the early versus deferred CP group. The in-hospital mortality rate was 17.9% versus 6.7% (OR 3.04, 95% CI 0.54–17.17 p = 0.246), mechanical ventilation 17.9% versus 6.7% (OR 3.04, 95% CI 0.54–17.17, p = 0.246), and prolonged hospitalization 21.4% versus 30.0% (OR 0.64, 95% CI, 0.19–2.10, p = 0.554) in the early versus deferred CP group, respectively. The viral clearance rate on day 3 (26% versus 8%, p = 0.204) and day 7 (38% versus 19%, p = 0.374) did not differ between groups. Two patients experienced serious adverse events within 6 hours after plasma transfusion. The main limitation of this study is the lack of statistical power to detect a smaller but clinically relevant therapeutic effect of CP, as well as not having confirmed neutralizing antibodies in donor before plasma infusion. CONCLUSIONS: In the present study, we failed to find evidence of benefit in mortality, length of hospitalization, or mechanical ventilation requirement by immediate addition of CP therapy in the early stages of COVID-19 compared to its use only in case of patient deterioration.
1000 Sacherschließung
gnd 1206347392 COVID-19
lokal Blood plasma
lokal Respiratory failure
lokal SARS CoV 2
lokal Respiratory infections
lokal Pneumonia
lokal Virus testing
lokal Randomized controlled trials
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0002-7223-9665|https://orcid.org/0000-0002-0234-5876|https://orcid.org/0000-0002-9361-4049|https://orcid.org/0000-0002-2836-9817|https://orcid.org/0000-0002-5569-6485|https://frl.publisso.de/adhoc/uri/RmVycsOpcywgTWFyY2VsYSA=|https://frl.publisso.de/adhoc/uri/Q2hhbmcsIE1heWxpbmcg|https://frl.publisso.de/adhoc/uri/Vml6Y2F5YSwgQ2VjaWxpYSA=|https://frl.publisso.de/adhoc/uri/TW9uZGFjYSwgU2ViYXN0acOhbiA=|https://orcid.org/0000-0002-8746-1111|https://orcid.org/0000-0002-0978-9891|https://orcid.org/0000-0003-3715-9886|https://orcid.org/0000-0001-9603-937X|https://frl.publisso.de/adhoc/uri/UGl6YXJybywgQWxlamFuZHJhIA==|https://orcid.org/0000-0002-8867-1970|https://orcid.org/0000-0002-2156-8290|https://orcid.org/0000-0002-0265-808X|https://frl.publisso.de/adhoc/uri/RmVycmFkYSwgTWFyY2VsYSA=|https://orcid.org/0000-0002-9369-2856|https://frl.publisso.de/adhoc/uri/QmVsdHLDoW4tUGF2ZXosIENhcm9saW5hIA==|https://orcid.org/0000-0003-0945-2970|https://frl.publisso.de/adhoc/uri/VmFsaWVudGUtRWNoZXZlcnLDrWEsIEZlcm5hbmRvIA==|https://frl.publisso.de/adhoc/uri/Q2FnbGV2aWMsIENocmlzdGlhbiA=|https://frl.publisso.de/adhoc/uri/TWFoYXZlLCBNYXVyaWNpbyA=|https://frl.publisso.de/adhoc/uri/U2VsbWFuLCBDYXJvbGluYSA=|https://orcid.org/0000-0002-1269-7322|https://orcid.org/0000-0003-1140-2067|https://frl.publisso.de/adhoc/uri/VmlsbGFycm9lbC1Fc3BpbmRvbGEsIEZyYW56IA==|https://frl.publisso.de/adhoc/uri/QmFsbWFjZWRhLCAgQ2FybG9zIA==|https://orcid.org/0000-0001-9564-9512|https://frl.publisso.de/adhoc/uri/UGVyZWlyYSwgSmFpbWUg|https://frl.publisso.de/adhoc/uri/TmVydmksIEJydW5vIA==
1000 Label
1000 Förderer
  1. Fondo de Adopción Tecnológica SiEmpre |
  2. Ministerio de Ciencia, Tecnología, Conocimiento e Innovación, Chile |
  3. ENEL Chile S.A. |
1000 Fördernummer
  1. -
  2. -
  3. -
1000 Förderprogramm
  1. SOFOFA Hub
  2. -
  3. -
1000 Dateien
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer Fondo de Adopción Tecnológica SiEmpre |
    1000 Förderprogramm SOFOFA Hub
    1000 Fördernummer -
  2. 1000 joinedFunding-child
    1000 Förderer Ministerio de Ciencia, Tecnología, Conocimiento e Innovación, Chile |
    1000 Förderprogramm -
    1000 Fördernummer -
  3. 1000 joinedFunding-child
    1000 Förderer ENEL Chile S.A. |
    1000 Förderprogramm -
    1000 Fördernummer -
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6426352.rdf
1000 Erstellt am 2021-03-23T17:10:16.019+0100
1000 Erstellt von 315
1000 beschreibt frl:6426352
1000 Bearbeitet von 315
1000 Zuletzt bearbeitet 2021-04-22T12:39:23.900+0200
1000 Objekt bearb. Thu Apr 22 12:39:23 CEST 2021
1000 Vgl. frl:6426352
1000 Oai Id
  1. oai:frl.publisso.de:frl:6426352 |
1000 Sichtbarkeit Metadaten public
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