Evidence map›Paper›PMID 34244316›Full record

Trial reportThe European respiratory journal2022

Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial.

Leo Sekine, Beatriz Arns, Bruna R Fabro, Murillo M Cipolatt, Rafael R G Machado, Edison L Durigon, Edino Parolo, José Augusto S Pellegrini, Marina V Viana, Patrícia Schwarz and 19 more

Abstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in The European respiratory journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 14 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 14 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
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  6. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
    Pooled it
  7. Guideline
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  15. Trial
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors.

Leo SekineTransfusion Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.ORCID 0000-0002-7140-4980
Beatriz ArnsInfectious Diseases Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Bruna R FabroInfectious Diseases Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Murillo M CipolattInfectious Diseases Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Rafael R G MachadoDept of Microbiology, Institute of Biomedical Sciences, University of São Paulo, São Paulo, Brazil.ORCID 0000-0001-6974-5092
Edison L DurigonDept of Microbiology, Institute of Biomedical Sciences, University of São Paulo, São Paulo, Brazil.
Edino ParoloCritical Care Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
José Augusto S PellegriniCritical Care Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Marina V VianaCritical Care Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Patrícia SchwarzCritical Care Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Thiago C LisboaCritical Care Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
José Miguel S DoraInternal Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.ORCID 0000-0003-3386-713X
Julia P PortichClinical Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Alessandra A PazClinical Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Lucia SillaClinical Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Almeri M BalsanTransfusion Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Felipe da-Silva SchirmerTransfusion Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Juliana P M FranzTransfusion Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Luciana M da-SilveiraTransfusion Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Raquel C BreunigTransfusion Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Viviana PetersenTransfusion Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Monalisa SosnoskiTransfusion Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Nanci F MesquitaTransfusion Medicine Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Fabiana Caroline Z VolpatoLaboratório de Diagnóstico de SARS-CoV-2, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Daniel SganzerlaResearch Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
Maicon FalavignaResearch Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
Regis G RosaIntensive Care Service, Hospital Moinhos de Vento, Porto Alegre, Brazil.
Alexandre P ZavasckiInfectious Diseases Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil azavascki@hcpa.edu.br.ORCID 0000-0001-5331-4837
PLACOVID Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effects of convalescent plasma (CP) therapy in hospitalised patients with coronavirus disease 2019 (COVID-19) remain uncertain. This study investigates the effect of CP on clinical improvement in these patients.

methodsThis 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.

resultsA total of 160 (80 in each arm) patients (66.3% critically ill, 33.7% severely ill) completed the trial. The median (interquartile range (IQR)) age was 60.5 (48-68) years; 58.1% were male and the median (IQR) time from symptom onset to randomisation was 10 (8-12) days. Neutralising antibody 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 group and 65.0% in the SOC group (difference -3.7%, 95% CI -18.8-11.3%). The results were similar in the severe and critically ill subgroups. There was no significant difference between CP+SOC and SOC groups in pre-specified secondary outcomes, including 28-day mortality, days alive and free of respiratory support and duration of invasive ventilatory support. Inflammatory and other laboratory marker values on days 3, 7 and 14 were similar between groups.

conclusionsCP+SOC did not result in a higher proportion of clinical improvement on day 28 in hospitalised patients with COVID-19 compared to SOC alone.

Indexed as

COVID-19AgedCOVID-19 SerotherapyHumansImmunization, PassiveMaleMiddle AgedPlasmaSARS-CoV-2Treatment Outcome

Identifiers

PMID34244316
PMCPMC8287736

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.