Convalescent plasma for outpatients with early COVID-19
| Autor: | Joan-Ramon Grifols, Jaap Jan Zwaginga, Julià Blanco, Pere Millat-Martinez, Anna Ruiz-Comellas, Andrea B. Troxel, Ellen van der Schoot, Bart J. A. Rijnders, Quique Bassat, Geert H. Groeneveld, Rosa Amado Simon, Dan Ouchi, Ignacio Blanco, Nan van Geloven, Corine H. GeurtsvanKessel, Francini Piccolo Ferreira, Bàrbara Baro, Arvind Gharbharan, Grigorios Papageourgiou, Andrea Alemany, Carlijn C E Jordans, Vanesa Garcia Garcia, Jordi Ara, Pierre Malchair, Francis Swaneveld, Casper Rokx, Joana Rodriguez Codina, Bonaventura Clotet, Marc Corbacho-Monné, Sebastián Videla, Oriol Mitjà, Anna Ramirez-Morros |
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| Rok vydání: | 2021 |
| Předmět: |
Mechanical ventilation
medicine.medical_specialty Coronavirus disease 2019 (COVID-19) business.industry medicine.medical_treatment Odds ratio Placebo medicine.disease Comorbidity law.invention Randomized controlled trial law Sample size determination Internal medicine medicine Credible interval business |
| ISSN: | 0462-1123 |
| DOI: | 10.1101/2021.11.30.21266810 |
| Popis: | BackgroundConvalescent plasma (CP) for hospitalized patients with COVID-19 has not demonstrated clear benefits. However, data on outpatients with early symptoms are scarce. We aimed to assess whether treatment with CP administered during the first 7 days of symptoms reduced the disease progression or risk of hospitalization of outpatients.MethodsTwo double-blind randomized trials (NCT04621123, NCT04589949) were merged with data pooling starting when ResultsOf 797 patients included, 390 received CP and 392 placebo. At baseline, they had a median age of 58 years, 1 comorbidity, symptoms for 5 days and 93% tested negative for SARS-CoV-2 S-protein IgG antibodies. Seventy-four patients were hospitalized, 6 required mechanical ventilation and 3 died. The OR of CP for an improved disease severity scale was 0.936 (credible interval (CI) 0.667-1.311). The OR for hospitalization or death was 0.919 (CI 0.592-1.416). The effect of CP on hospital admission or death was largest in patients with ≤5 days of symptoms (OR 0.658, 95% CI 0.394-1.085). CP did not decrease the time to full symptom resolution (p=0.62).ConclusionTreatment with CP of outpatients in the first 7 days of symptoms did not improve the outcome of COVID-19. The possible beneficial effect in patients with ≤5 days of symptoms requires further study.RegistrationNCT04621123 and NCT04589949 on https://www.clinicaltrials.govFunding sourceZONMW, the Netherlands, grant number 10430062010001.SUPPORT-E, grant number 101015756YoMeCorono, www.tomecorono.comThe Fight AIDS and Infectious Diseases Foundation with funding from the pharmaceutical company Grifols S.A |
| Databáze: | OpenAIRE |
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