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, Tiziana Francisci, Huijing Hu, Clara Pecoraro, Franca Danielle, Luciana Labanca, Anna Maria Bordiga, Marco Lorenzi, Giovanni Camisasca, Osvaldo Giachino, Mauro Pagliarino, Piero Ottone, Ilvana Tiziana Donatella Scuvera, Roberto Guaschino, Roberto Freilone, Pierluigi Berti, Fabrizia Pittaluga, Maria Avolio, Cristina Costa, Samuele Raso, Aurora Nucci, Massimo Milan, Alessandra Baffa, Alessandra Russo, Antonella Tornello, Laura Maddalena, Grazia Delios, Fabio Paolo Marletto, Anna Grazia De Micheli, Alessio Mattei, Stefano Baldassano, Francesca Canta, Maria Luisa Russo, Daniele Bergamo, Francesco Vitale, Marco Maria Liccardi, Alessandra Chinaglia, Andrea Calcagno, Marcella Converso, Chiara Aldieri, Valentina Libanore, Ilaria Blangetti, Valentina Benedetti, Barbara Mitola, Gitana Scozzari, MD Franco Castagno, MD Adriano Valfrè, MSc Gabriella Rizzioli, Teresa D’amato, MSc Cristina Crocillà, MSc Silvana Naselli, MSc Valentino Granero, MSc Grazia Cornagliotto, MSc Graziella Lucania, MSc Cristiana Scaglia, Francesca Ferro, MSc Carmela Solimine, MSc Monica Ricotti, Cristina Gilestro, Remigio Roncato, Angela Palladino, Daniela Ongaro, Giulia Anna Poggio, MD Chiara Chiappero, Simone Mornese Pinna, MD Silvia Scabini, MD Federico Vischia, MD Maria Grazia Gregoretti, MD Enrico Lupia, Prof Luca Brazzi, Prof Carlo Albera, MD Luca Scaglione, MD Valter Gallo, MD Claudio Norbiato, MD Roberto Albiani, MD Bruno Lucio Sini, MD Andrea Fassiola, MD Alessandro Locatelli, Giovanni Di Perri, MD Mauro Navarra, MD Isabella Gardini, MD Aurora Ciardiello, Rita La Grotta, Anna De Rosa, MD Paola Pasquino, MD Gilberto Fiore, MD Orietta Franza, MD Paola Artoni, MD Stefano Meinardi, MD Liliana Calosso, MD Paola Molino, MD Maria Grazia Veglio, MD Tiziana Beltramo, MD Odetta Camerini, MD Karol Giancaspero, MD Franca Napoli, MD Alberto Perboni, MD Emanuela Messa, MD Fabrizio Buffolo, MD Fiammetta Pagnozzi, MD Stefania Bertone, MD Lorenzo Lutri, MD Umberto Gravante, Petros Sacchetti, MD Alessandra Pavan, MD Enzo Castenetto, MD Marco Novelli, MD Marco Tucciarone, MD Patrizia Ocello, MD Giulia Guido, MD Chiara Frascaroli, Daniela Maria Luisa Vivenza, MD Francesca Patti, MD Laura Lorenzelli, MD Guido Balduzzi, MD Deborah Ratti, Laura Mazzucco, Valeria Balbo, MD Francesca Pollis, MD Sabrina Leoncino, MD Chiara Lupo, MD Daniele Romano, MD Silvia Ziccardi, MD Melania Marmifero, MD Guido Chichino, MD Mario Salio, MD Giuseppe Aiosa, MD Riccardo Boverio, MD Ilaria Avonto, MD Sara Ghiotto, MD Riccardo Balbo, MD Vincenza Nico, MD Chiara Aguzzi, Maria Chiara Pellegrino, Maristella Prucca, MSc Lucia Assunta Longa, Laura Perotti, Federica Piovano, MD Luca Ambrogio, MD Marco Formica, MD Elisa Monge, MD Flavia Arena, MD Nicoletta Barzaghi, MD Silvia Tavera, MD Mariaelisa Canepari, MD Guido Strani, MD Fulvio Pomero, MD Maria Grazia Cianci, MD Mariella Gianarda, MD Leonardo Ruscitto, MD Daniel De Martino, MD Sandro Macchi, MD Michele Montagnana, MD Vladimiro Grandinetti, MD Silvia Magnani, MD Elisabetta Radin, MD Valentina Pellu, MD Monica Meucci, MD Erika Noè, MD Paola Torti, MD Luca Montagnani, MD Giulio Doveri, Gabriella Giustetto, Costantino Avdis, Marco Prina, Franco Eliantonio, MD Francesco Lemut, MD Giuseppe Semino, Palmina Spidalieri, MD Domenico Vallino, MD Roberto Prota, MD Gabriella Buono, MD Vincenzo Segala, Maria Grazia Milia, MD Franco Aprà, MD Sergio Livigni, MD Emilpaolo Manno, MD Giuseppe Caula, MD Emanuela Vitali, MD Nicola Liuzzi, MD Mauro Pastorelli, MD Pietro Caironi, MD Federica Gamna, MD Bruno Scapino, MD Lorenzo Gurioli, MD Emanuele Magro, MD Giuseppe Roberti, MD Gian Mario Santamaria, MD Antonella Daffonchio, MD Paola Varese, MD Gianfranco Ghiazza, MD Margherita Girino, Carolina Pelazza, MD Fabrizio Racca, MD Mirco Grillo, Valerio Del Bono, MD Giorgio Gianotto, MD Enzo Aluffi, MD Enrico Ravera
BMC Infectious Diseases, doi:10.1186/s12879-022-07716-5
Background: The 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. Methods: To 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
Abbreviations
Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1186/ s12879-022-07716-5.
Additional file 1. Supplementary appendix.
Author contributions PMM is the Chief Investigator; she conceived the study, led the proposal and protocol development and wrote the manuscript. GCi, FGDR, CG, SDA, FS, ACas, ML, GCa, OG, AMB, AT, LB, LS, Cav, MPri, FE, contributed to study design and to development of the proposal. GCi was the lead trial methodologist. FS, ACas were trial metodologists and they analyzed results. FD, LL, designed logistic organization for CCP preparation and distribution. TF, HH, CP, MP, PO, ITS, RG, RF, PB, AN, LMa, FPM, SR, AB, AR, MMi, GD, FCas, AV, RR, AP, DO, RA, BLS, IG, ACi, RLG, ADR, LC, TB, OC, KG, FN, MT, PO, GBa, LMaz, VB, MPr, LAL, MGC, MGia, LR, DDM, SMa, MMo, GSe, PSp, GGia organized donors' selection and recruitment and plasma and CCP collection in their hospitals. TF, HH, CP, GD, GGu, CF, DMLV, FPol, SLe, ChL, DRo, SZ, MeMa, IA, SG, RBa, VN, CA, MCP, ST, MCa, GSt, VlG, organized patients' data collection for their centers. BM, GSc, CP were responsible for coordinating Hospital organization for the trial. RC, VG, FD, LL, FP, MA, CC, MGM, organized and performed all donors and patients serological and RT-PCR tests. GC, GL, CSc, FF, CSo, MR, CG, organized plasma and CCP fractionation, treatment and stockage. GR, TDA, CC, SN, VaG, LP, FPio, GGiu, organized CCP and plasma blinding..
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'abstract': '<jats:title>Abstract</jats:title><jats:sec>\n'
' <jats:title>Background</jats:title>\n'
' <jats:p>The 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.\n'
'</jats:p>\n'
' </jats:sec><jats:sec>\n'
' <jats:title>Methods</jats:title>\n'
' <jats:p>To 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\xa0days from the '
'onset of respiratory distress. Patients were randomly assigned in a 1:1:1 ratio to standard '
'of care (n\u2009=\u200960) or standard of care\u2009+\u2009three units of standard plasma '
'(n\u2009=\u200960) or standard of care\u2009+\u2009three units of high-titre convalescent '
'plasma (n\u2009=\u200960) 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.\n'
'</jats:p>\n'
' </jats:sec><jats:sec>\n'
' <jats:title>Results</jats:title>\n'
' <jats:p>180 patients (133/180 [73.9%] males, mean age 66.6 years [IQR 57–73]) '
'were enrolled a median of 8\xa0days 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\u2009=\u2009'
'0.694) and 25% in Standard plasma (RR 1.23; 95%CI, 0.63–2.37, P\u2009=\u20090.544). Time to '
'viral clearance from respiratory tract was 21\xa0days 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.\n'
'</jats:p>\n'
' </jats:sec><jats:sec>\n'
' <jats:title>Conclusions</jats:title>\n'
' <jats:p>Neither high-titer Convalescent nor Standard plasma improve outcomes '
'of COVID-19 patients with acute respiratory failure.</jats:p>\n'
' <jats:p><jats:italic>Trial Registration</jats:italic> Clinicaltrials.gov '
'Identifier: NCT04428021. First posted: 11/06/2020</jats:p>\n'
' </jats:sec>',
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'title': 'Convalescent or standard plasma versus standard of care in the treatment of COVID-19 patients '
'with respiratory impairment: short and long-term effects. A\xa0three-arm randomized controlled '
'clinical trial',
'prefix': '10.1186',
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{'given': 'Nadia', 'family': 'Birocco', 'sequence': 'additional', 'affiliation': []},
{'given': 'Tiziana', 'family': 'Francisci', 'sequence': 'additional', 'affiliation': []},
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{'given': 'Clara', 'family': 'Pecoraro', 'sequence': 'additional', 'affiliation': []},
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{'given': 'Pierluigi', 'family': 'Berti', 'sequence': 'additional', 'affiliation': []},
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{'given': 'Massimo', 'family': 'Milan', 'sequence': 'additional', 'affiliation': []},
{'given': 'Alessandra', 'family': 'Baffa', 'sequence': 'additional', 'affiliation': []},
{'given': 'Alessandra', 'family': 'Russo', 'sequence': 'additional', 'affiliation': []},
{'given': 'Antonella', 'family': 'Tornello', 'sequence': 'additional', 'affiliation': []},
{'given': 'Laura', 'family': 'Maddalena', 'sequence': 'additional', 'affiliation': []},
{'given': 'Grazia', 'family': 'Delios', 'sequence': 'additional', 'affiliation': []},
{'given': 'Fabio Paolo', 'family': 'Marletto', 'sequence': 'additional', 'affiliation': []},
{'given': 'Anna Grazia', 'family': 'De Micheli', 'sequence': 'additional', 'affiliation': []},
{'given': 'Alessio', 'family': 'Mattei', 'sequence': 'additional', 'affiliation': []},
{'given': 'Stefano', 'family': 'Baldassano', 'sequence': 'additional', 'affiliation': []},
{'given': 'Francesca', 'family': 'Canta', 'sequence': 'additional', 'affiliation': []},
{'given': 'Maria Luisa', 'family': 'Russo', 'sequence': 'additional', 'affiliation': []},
{'given': 'Daniele', 'family': 'Bergamo', 'sequence': 'additional', 'affiliation': []},
{'given': 'Francesco', 'family': 'Vitale', 'sequence': 'additional', 'affiliation': []},
{'given': 'Marco Maria', 'family': 'Liccardi', 'sequence': 'additional', 'affiliation': []},
{'given': 'Alessandra', 'family': 'Chinaglia', 'sequence': 'additional', 'affiliation': []},
{'given': 'Andrea', 'family': 'Calcagno', 'sequence': 'additional', 'affiliation': []},
{'given': 'Marcella', 'family': 'Converso', 'sequence': 'additional', 'affiliation': []},
{'given': 'Chiara', 'family': 'Aldieri', 'sequence': 'additional', 'affiliation': []},
{'given': 'Valentina', 'family': 'Libanore', 'sequence': 'additional', 'affiliation': []},
{'given': 'Ilaria', 'family': 'Blangetti', 'sequence': 'additional', 'affiliation': []},
{'given': 'Valentina', 'family': 'Benedetti', 'sequence': 'additional', 'affiliation': []},
{'given': 'Barbara', 'family': 'Mitola', 'sequence': 'additional', 'affiliation': []},
{'given': 'Gitana', 'family': 'Scozzari', 'sequence': 'additional', 'affiliation': []},
{'name': 'the PLACO COVID Study Group', 'sequence': 'additional', 'affiliation': []},
{'given': 'Franco', 'family': 'Castagno', 'sequence': 'additional', 'affiliation': []},
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{'given': 'Teresa', 'family': 'D’Amato', 'sequence': 'additional', 'affiliation': []},
{'given': 'Cristina', 'family': 'Crocillà', 'sequence': 'additional', 'affiliation': []},
{'given': 'Silvana', 'family': 'Naselli', 'sequence': 'additional', 'affiliation': []},
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