ORCHESTRA Delphi consensus: diagnostic and therapeutic management of SARS-CoV-2 infection in solid organ transplant recipients

Beatrice Tazza; Natascia Caroccia; Alice Toschi; Renato Pascale; Effrosyni Gkrania-Klotsas; Paula Olivares Navarro; Lorenzo Maria Canziani; Alessandro Tavelli; Andrea Antinori; Paolo Antonio Grossi; Maddalena Peghin; Evelina Tacconelli; Zaira Raquel Palacios-Baena; Pierluigi Viale; Maddalena Giannella; Expert team and ORCHESTRA WP4 working group. Expert team Group Authorship; WP4 Working Group

doi:10.1016/j.cmi.2025.02.010

ORCHESTRA Delphi consensus: diagnostic and therapeutic management of SARS-CoV-2 infection in solid organ transplant recipients

Clin Microbiol Infect. 2025 Feb 13:S1198-743X(25)00069-2. doi: 10.1016/j.cmi.2025.02.010. Online ahead of print.

Authors

Beatrice Tazza¹, Natascia Caroccia¹, Alice Toschi², Renato Pascale³, Effrosyni Gkrania-Klotsas⁴, Paula Olivares Navarro⁵, Lorenzo Maria Canziani⁶, Alessandro Tavelli⁷, Andrea Antinori⁸, Paolo Antonio Grossi⁹, Maddalena Peghin⁹, Evelina Tacconelli⁶, Zaira Raquel Palacios-Baena⁵, Pierluigi Viale³, Maddalena Giannella¹⁰; Expert team and ORCHESTRA WP4 working group. Expert team Group Authorship; WP4 Working Group

Collaborators

Ligia Pierrotti, Oriol Manuel, Alessandra Mularoni, Robin Avery, Maria Paniagua, Michele Bartoletti, Javier Carbone, Maricela Valerio, Nicolas Mueller, Ibai Los-Arcos, Marta Bodro, Effrossyni Gkrania-Klotsas, Elena Graziano, Maria Luisa Balsamo, Matteo Rinaldi, Renato Pascale, Cecilia Bonazzetti, Maddalena Giannella, Beatrice Tazza, Paolo Grossi, Maddalena Peghin, Elena Addis, Anna Azzini, Virginia Almadana Pacheco, Maria Giulia Caponcello, Elena Carrara, Salvatore Cataudella, Marta Camici, Antonio Cascio, Giorgia Comai, Alessandro Cozzi-Lepri, Chiara Dellacasa, Antonella d'Arminio Monforte, Liliana Gabrielli, Elisa Gentilotti, Dino Gibertoni, Tiziana Lazzarotto, Inmaculada López, Gaia Maccarrone, Giordano Madeddu, Fulvia Mazzaferri, Maria Cristina Morelli, Giovanni Pellicanò, Patricia Pérez Palacios, Stefania Piconi, Luciano Potena, Alessandra Rodanò, Jesús Rodríguez Baño, Elisa Rossi, Nadia Sangiovanni, Elena Salvaterra, Andrea Santoro, Alessandro Visentin

Affiliations

¹ Infectious Diseases Unit, Department for Integrated Infectious Risk Management, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
² Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
³ Infectious Diseases Unit, Department for Integrated Infectious Risk Management, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
⁴ Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom; Department of Infectious Diseases, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom.
⁵ Unidad Clínica de Enfermedades Infecciosas y Microbiología, Instituto de Biomedicina de Sevilla/CSIC, Hospital Universitario Virgen Macarena, Seville, Spain; Departamento de Medicina, Universidad de Sevilla, Seville, Spain; CIBERINFEC, Instituto de Salud Carlos III, Madrid, Spain.
⁶ Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
⁷ ICONA Foundation, Milan, Italy.
⁸ Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy.
⁹ Infectious and Tropical Diseases Unit, Department of Medicine and Surgery, University of Insubria, ASST Sette Laghi, Varese, Italy.
¹⁰ Infectious Diseases Unit, Department for Integrated Infectious Risk Management, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy. Electronic address: maddalena.giannella@unibo.it.

PMID: 39954948
DOI: 10.1016/j.cmi.2025.02.010

Abstract

Objectives: We aimed to address existing knowledge gaps regarding risk stratification, best use of diagnostic resources, optimal treatment, and general management of SARS-CoV-2 infection in solid organ transplant (SOT) recipients. As high-quality evidence specific to this fragile population is lacking, our final aim was to provide an expert consensus evidence-informed guidance that can aid clinicians in their daily practice.

Methods: This study was conducted within the Working Package 4 (fragile population cohorts) of the H2020-funded ORCHESTRA study (https://orchestra-cohort.eu). Eight infectious disease and one clinical pharmacology specialists conducted a comprehensive scoping literature review which covered five key areas: the role of SOT as a risk factor for evolution to severe disease; the optimal use of diagnostic resources, considering cost-benefit ratios and appropriateness of active screening; population-specific therapeutic management, including antiviral use and drug-drug interactions and appropriate duration of treatment; the potential need for withdrawal of immunosuppressive agents and management of potential donors and recipients with recent and/or ongoing SARS-CoV-2 infection at the time of transplantation. On the basis of this review, a 28-item questionnaire was developed and administered to a panel of experts through two rounds, following the Delphi methodology.

Results: The panel consisted of 21 experts, 13 females and 8 males, from Italy (n = 11), Spain (n = 5), Switzerland (n = 2), Brazil (n = 1), United States (n = 1), and United Kingdom (n = 1). Consensus was achieved for 18 out of 28 items after the first round and for 9 out of 13 items after the second round, according to agreement/disagreement levels obtained for each question and round, ten statements were finally produced.

Discussion: The consensus statements derived from this study offer a framework for standardizing care and improving outcomes in SOT recipients affected by SARS-CoV-2 infection in a field where high-quality evidence specific to this high-risk population is currently lacking.

Keywords: COVID-19; Consensus; Delphi; Diagnosis; Risk of progression; SOT; Treatment.