Evidence map›Paper›PMID 36418984›Full record

Trial reportBMC infectious diseases2022

Convalescent or standard plasma versus standard of care in the treatment of COVID-19 patients with respiratory impairment: short and long-term effects. A three-arm randomized controlled clinical trial.

Paola Maria Manzini, Giovannino Ciccone, Francesco Giuseppe De Rosa, Rossana Cavallo, Valeria Ghisetti, Sergio D'Antico, Claudia Galassi, Fabio Saccona, Anna Castiglione, Nadia Birocco and 45 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04428021 (Effectiveness of Adding Standard Plasma or COVID-19 Convalescent Plasma to Standard Treatment, Versus Standard Treatment Alone, in Patients With Recent Onset of COVID-19 Respiratory Failure. A Randomized, Three-arms, Phase 2 Trial), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
1.0field-weighted citation impact, top 23% of its field
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.

NCT04428021 phase2completednot on this map

Effectiveness of Adding Standard Plasma or COVID-19 Convalescent Plasma to Standard Treatment, Versus Standard Treatment Alone, in Patients With Recent Onset of COVID-19 Respiratory Failure. A Randomized, Three-arms, Phase 2 Trial

TypeinterventionalSponsorA.O.U. Città della Salute e della ScienzaRan2020 to 2021Enrolled180ConditionsCOVID-19ArmsStandard Therapy Protocol (STP), STP + Standard Plasma (SP), STP + COVID-19 Convalescent Plasma (CP)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Convalescent plasma for people with COVID-19.The Cochrane database of systematic reviews · 2026
    Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Insights and innovations in Blood Transfusion.Blood transfusion = Trasfusione del sangue · 2024
    Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

55 authors at 20 institutions in 1 country.

Paola Maria ManziniTransfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy. pmanzini@cittadellasalute.to.it.
Giovannino CicconeUnit of Clinical Epidemiology, University Hospital City of Science and Health Turin, CPO Piemonte, Turin, Italy.
Francesco Giuseppe De RosaDepartment of Medical Science, University of Turin Faculty of Medicine and Surgery, Turin, Italy.
Rossana CavalloLaboratory of Microbiology and Virology, University Hospital City of Science and Health Turin, Turin, Italy.
Valeria GhisettiLaboratory of Microbiology and Virology, Amedeo di Savoia Hospital, Turin, Italy.
Sergio D'AnticoTransfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy.
Claudia GalassiUnit of Clinical Epidemiology, University Hospital City of Science and Health Turin, CPO Piemonte, Turin, Italy.
Fabio SacconaUnit of Clinical Epidemiology, University Hospital City of Science and Health Turin, CPO Piemonte, Turin, Italy.
Anna CastiglioneUnit of Clinical Epidemiology, University Hospital City of Science and Health Turin, CPO Piemonte, Turin, Italy.
Nadia BiroccoOncology Department, University Hospital City of Science and Health Turin, Turin, Italy.
Tiziana FrancisciTransfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy.
Huijing HuTransfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy.
Clara PecoraroTransfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy.
Franca DanielleTransfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy.
Luciana LabancaTransfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy.
Anna Maria BordigaTransfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy.
Marco LorenziImmunohematology and Transfusion Medicine, S Croce and Carle Cuneo Hospital District, Cuneo, Italy.
Giovanni CamisascaTransfusion Medicine and Blood Establishment, Holy Trinity Hospital Borgomanero, Borgomanero, Italy.
Osvaldo GiachinoTransfusion Medicine, San Giovanni Bosco Hospital, Turin, Italy.
Mauro PagliarinoMaternal, Pediatric and Trauma Transfusion Medicine, University Hospital City of Science and Health Turin, Turin, Italy.
Piero OttoneTransfusion Medicine, San Luigi Gonzaga University Hospital, Orbassano, Italy.
Ilvana Tiziana Donatella ScuveraImmunohematology and Transfusion Medicine, Cardinal Massaia Hospital of Asti, Asti, Italy.
Roberto GuaschinoTransfusion Medicine, Saints Anthony and Biagio and Cesare Arrigo Alessandria National Hospital, Alessandria, Italy.
Roberto FreiloneTransfusion Medicine, Ivrea Hospital, Ivrea, Italy.
Pierluigi BertiImmunohematology and Transfusion Medicine, Umberto Parini Hospital, Aosta, Italy.
Fabrizia PittalugaLaboratory of Microbiology and Virology, University Hospital City of Science and Health Turin, Turin, Italy.
Maria AvolioLaboratory of Microbiology and Virology, University Hospital City of Science and Health Turin, Turin, Italy.
Cristina CostaLaboratory of Microbiology and Virology, University Hospital City of Science and Health Turin, Turin, Italy.
Samuele RasoMaternal, Pediatric and Trauma Transfusion Medicine, University Hospital City of Science and Health Turin, Turin, Italy.
Aurora NucciMaternal, Pediatric and Trauma Transfusion Medicine, University Hospital City of Science and Health Turin, Turin, Italy.
Massimo MilanTransfusion Medicine, San Giovanni Bosco Hospital, Turin, Italy.
Alessandra BaffaTransfusion Medicine, San Giovanni Bosco Hospital, Turin, Italy.
Alessandra RussoTransfusion Medicine, San Giovanni Bosco Hospital, Turin, Italy.
Antonella TornelloImmunohematology and Transfusion Medicine, S Croce and Carle Cuneo Hospital District, Cuneo, Italy.
Laura MaddalenaImmunohematology and Transfusion Medicine, S Croce and Carle Cuneo Hospital District, Cuneo, Italy.
Grazia DeliosTransfusion Medicine, Ivrea Hospital, Ivrea, Italy.
Fabio Paolo MarlettoImmunohematology and Transfusion Medicine, Umberto Parini Hospital, Aosta, Italy.
Anna Grazia De MicheliMedical Emergency Division, University Hospital City of Science and Health Turin, Turin, Italy.
Alessio MatteiPulmunology Unit, University Hospital City of Science and Health Turin, Turin, Italy.
Stefano BaldassanoDepartment of Clinical and Biological Science, Faculty of Medicine and Surgery, University of Turin, Turin, Italy.
Francesca CantaInfectious Diseases Unit, University Hospital City of Science and Health Turin, Turin, Italy.
Maria Luisa RussoInternal Medicine Unit, Santa Croce Hospital of Moncalieri, Moncalieri, Italy.
Daniele BergamoInternal Medicine Unit, Santa Croce Hospital of Moncalieri, Moncalieri, Italy.
Francesco VitaleInternal Medicine Unit, Ordine Mauriziano Di Torino Hospital, Turin, Italy.
Marco Maria LiccardiIntensive Care Unit, Hospital of Chivasso, Chivasso, Italy.
Alessandra ChinagliaCardiology Unit, Martini Hospital, Turin, Italy.
Andrea CalcagnoInfectious Diseases Unit, Department of Medical Sciences, University of Turin Faculty of Medicine and Surgery, Turin, Italy.
Marcella ConversoIntensive Care Unit, San Giovanni Bosco Hospital, Turin, Italy.
Chiara AldieriInfectious Diseases, S Croce and Carle Cuneo Hospital District, Cuneo, Italy.
Valentina LibanoreInfectious Diseases Unit, Cardinal Massaia Hospital of Asti, Asti, Italy.
Ilaria BlangettiIntensive Care Unit, Mondovì Hospital, Mondovì, Italy.
Valentina BenedettiInternal Medicine Unit, Mondovì Hospital, Mondovì, Italy.
Barbara MitolaHospital Medical Direction, Ordine Mauriziano di Torino Hospital, Turin, Italy.
Gitana ScozzariMolinette Hospital Medical Direction, University Hospital City of Science and Health Turin, Turin, Italy.
PLACO COVID Study Group
Piedmont Reference Center for Epidemiology and Cancer Prevention · ITAzienda Sanitaria Ospedaliera S.Croce e Carle Cuneo · ITOspedale San Giovanni Bosco · ITAzienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo · ITOspedale Civile Di Ivrea · ITA. O. Ordine Mauriziano di Torino · ITOspedale San Luigi Gonzaga · ITAzienda Sanitaria Locale di Asti · ITOspedale Amedeo di Savoia · ITOspedale Civile Edoardo Agnelli · ITOspedale San Pietro Fatebenefratelli · ITUniversity of Turin · ITAzienda Sanitaria Locale Alessandria · ITOspedale Martini · ITOspedale Regina Margherita · ITOspedale di Rivoli · ITOspedale di Santo Spirito · ITOspedale Maggiore di Chieri · ITOspedale San Giacomo Apostolo · ITSEQUOIA (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of early treatment with convalescent plasma in patients with COVID-19 is debated. Nothing is known about the potential effect of other plasma components other than anti-SARS-CoV-2 antibodies.

methodsTo determine whether convalescent or standard plasma would improve outcomes for adults in early phase of Covid19 respiratory impairment we designed this randomized, three-arms, clinical trial (PLACO COVID) blinded on interventional arms that was conducted from June 2020 to August 2021. It was a multicentric trial at 19 Italian hospitals. We enrolled 180 hospitalized adult patients with COVID-19 pneumonia within 5 days from the onset of respiratory distress. Patients were randomly assigned in a 1:1:1 ratio to standard of care (n = 60) or standard of care + three units of standard plasma (n = 60) or standard of care + three units of high-titre convalescent plasma (n = 60) administered on days 1, 3, 5 after randomization. Primary outcome was 30-days mortality. Secondary outcomes were: incidence of mechanical ventilation or death at day 30, 6-month mortality, proportion of days with mechanical ventilation on total length of hospital stay, IgG anti-SARS-CoV-2 seroconversion, viral clearance from plasma and respiratory tract samples, and variations in Sequential Organ Failure Assessment score. The trial was analysed according to the intention-to-treat principle.

results180 patients (133/180 [73.9%] males, mean age 66.6 years [IQR 57-73]) were enrolled a median of 8 days from onset of symptoms. At enrollment, 88.9% of patients showed moderate/severe respiratory failure. 30-days mortality was 20% in Control arm, 23% in Convalescent (risk ratio [RR] 1.13; 95% confidence interval [CI], 0.61-2.13, P = 0.694) and 25% in Standard plasma (RR 1.23; 95%CI, 0.63-2.37, P = 0.544). Time to viral clearance from respiratory tract was 21 days for Convalescent, 28 for Standard plasma and 23 in Control arm but differences were not statistically significant. No differences for other secondary endpoints were seen in the three arms. Serious adverse events were reported in 1.7%, 3.3% and 5% of patients in Control, Standard and Convalescent plasma arms respectively.

conclusionsNeither high-titer Convalescent nor Standard plasma improve outcomes of COVID-19 patients with acute respiratory failure. Trial Registration Clinicaltrials.gov Identifier: NCT04428021. First posted: 11/06/2020.

Indexed as

COVID-19Respiratory InsufficiencyAgedCOVID-19 SerotherapyFemaleHumansMaleMiddle AgedPlasmaStandard of CareCOVID-19 convalescent plasmaCOVID-19 outcomesCOVID-19 therapyRandomized clinical trial

Identifiers

PMID36418984
PMCPMC9682750
OpenAlexW4309728893

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.