tetano
Editor, Senior Moderator
Eur Respir J
. 2021 Jul 8;2101471.
doi: 10.1183/13993003.01471-2021. Online ahead of print.
Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial
Leo Sekine[SUP] 1 2 [/SUP], Beatriz Arns[SUP] 3 [/SUP], Bruna R Fabro[SUP] 3 [/SUP], Murillo M Cipolatt[SUP] 3 [/SUP], Rafael R G Machado[SUP] 4 [/SUP], Edison L Durigon[SUP] 5 6 [/SUP], Edino Parolo[SUP] 6 [/SUP], José Augusto S Pellegrini[SUP] 6 [/SUP], Marina V Viana[SUP] 6 [/SUP], Patrícia Schwarz[SUP] 6 [/SUP], Thiago C Lisboa[SUP] 6 [/SUP], José Miguel S Dora[SUP] 7 8 [/SUP], Almeri M Balsan[SUP] 1 [/SUP], Felipe da-Silva Schirmer[SUP] 1 [/SUP], Juliana P M Franz[SUP] 1 [/SUP], Luciana M da-Silveira[SUP] 1 [/SUP], Raquel C Breunig[SUP] 1 [/SUP], Viviana Petersen[SUP] 1 [/SUP], Monalisa Sosnoski[SUP] 1 [/SUP], Nanci F Mesquita[SUP] 1 [/SUP], Fabiana Caroline Z Volpato[SUP] 9 10 [/SUP], Daniel Sganzerla[SUP] 11 [/SUP], Maicon Falavigna[SUP] 11 [/SUP], Regis G Rosa[SUP] 12 [/SUP], Alexandre P Zavascki[SUP] 1 2 [/SUP], PLACOVID Study Group
Affiliations
Abstract
Background: The effects of convalescent plasma (CP) therapy hospitalised patients with coronavirus disease 2019 (COVID-19) remain uncertain. This study investigates the effect CP on clinical improvement in these patients.
Methods: This is an investigator-initiated, randomised, parallel arm, open-label, superiority clinical trial. Patients were randomly (1:1) assigned to two infusions of CP plus standard of care (SOC) or SOC alone. The primary outcome was the proportion of patients with clinical improvement 28 days after enrolment.
Results: A total of 160 (80 in each arm) patients (66.3% were critically ill and 33.7%, severe) completed the trial. The median age was 60.5 years (interquartile range [IQR], 48-68), 58.1% were men and the median time from symptom onset to randomisation was 10 days (IQR, 8-12). Neutralising antibodies titres >1:80 were present in 133 (83.1%) patients at baseline. The proportion of patients with clinical improvement on day 28 was 61.3% in the CP+SOC and 65.0% in the SOC group (difference, -3.7%; 95% Confidence Interval [CI], -18.8%-11.3%). The results were similar in the subgroups of severe and critically ill. There was no significant difference between CP+SOC and SOC groups in prespecified secondary outcomes, including 28-day mortality, days alive and free of respiratory support and duration of invasive ventilatory support. Inflammatory and other laboratorial markers values on days 3, 7 and 14 were similar between groups.
Conclusions: CP+SOC did not result in a higher proportion of clinical improvement on at day 28 in hospitalised patients with COVID-19 compared to SOC alone.
. 2021 Jul 8;2101471.
doi: 10.1183/13993003.01471-2021. Online ahead of print.
Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial
Leo Sekine[SUP] 1 2 [/SUP], Beatriz Arns[SUP] 3 [/SUP], Bruna R Fabro[SUP] 3 [/SUP], Murillo M Cipolatt[SUP] 3 [/SUP], Rafael R G Machado[SUP] 4 [/SUP], Edison L Durigon[SUP] 5 6 [/SUP], Edino Parolo[SUP] 6 [/SUP], José Augusto S Pellegrini[SUP] 6 [/SUP], Marina V Viana[SUP] 6 [/SUP], Patrícia Schwarz[SUP] 6 [/SUP], Thiago C Lisboa[SUP] 6 [/SUP], José Miguel S Dora[SUP] 7 8 [/SUP], Almeri M Balsan[SUP] 1 [/SUP], Felipe da-Silva Schirmer[SUP] 1 [/SUP], Juliana P M Franz[SUP] 1 [/SUP], Luciana M da-Silveira[SUP] 1 [/SUP], Raquel C Breunig[SUP] 1 [/SUP], Viviana Petersen[SUP] 1 [/SUP], Monalisa Sosnoski[SUP] 1 [/SUP], Nanci F Mesquita[SUP] 1 [/SUP], Fabiana Caroline Z Volpato[SUP] 9 10 [/SUP], Daniel Sganzerla[SUP] 11 [/SUP], Maicon Falavigna[SUP] 11 [/SUP], Regis G Rosa[SUP] 12 [/SUP], Alexandre P Zavascki[SUP] 1 2 [/SUP], PLACOVID Study Group
Affiliations
- PMID: 34244316
- DOI: 10.1183/13993003.01471-2021
Abstract
Background: The effects of convalescent plasma (CP) therapy hospitalised patients with coronavirus disease 2019 (COVID-19) remain uncertain. This study investigates the effect CP on clinical improvement in these patients.
Methods: This is an investigator-initiated, randomised, parallel arm, open-label, superiority clinical trial. Patients were randomly (1:1) assigned to two infusions of CP plus standard of care (SOC) or SOC alone. The primary outcome was the proportion of patients with clinical improvement 28 days after enrolment.
Results: A total of 160 (80 in each arm) patients (66.3% were critically ill and 33.7%, severe) completed the trial. The median age was 60.5 years (interquartile range [IQR], 48-68), 58.1% were men and the median time from symptom onset to randomisation was 10 days (IQR, 8-12). Neutralising antibodies titres >1:80 were present in 133 (83.1%) patients at baseline. The proportion of patients with clinical improvement on day 28 was 61.3% in the CP+SOC and 65.0% in the SOC group (difference, -3.7%; 95% Confidence Interval [CI], -18.8%-11.3%). The results were similar in the subgroups of severe and critically ill. There was no significant difference between CP+SOC and SOC groups in prespecified secondary outcomes, including 28-day mortality, days alive and free of respiratory support and duration of invasive ventilatory support. Inflammatory and other laboratorial markers values on days 3, 7 and 14 were similar between groups.
Conclusions: CP+SOC did not result in a higher proportion of clinical improvement on at day 28 in hospitalised patients with COVID-19 compared to SOC alone.