New ORCHESTRA Supplemental Issue: Clinical management of COVID-19 in fragile patients
- ID-CARE ID-CARE
- Jul 11
- 7 min read
During 2025, a supplemental issue titled “Clinical management of COVID-19 in fragile patients” was published in Clinical Microbiology and Infection, including five Delphi papers from the ORCHESTRA project, focussing specifically on the clinical management of COVID-19 in immunocompromised patients. Keep scrolling to see an overview of the articles, including links, authors and abstracts.
Canziani LM, d'Arminio Monforte A, Giannella M, Rodríguez-Baño J, Tacconelli E.
This article provides a short introduction to the supplementary, explaining the unmet clinical needs of patients, the proposed methodology of the papers, and their main results.
Tazza B, Caroccia N, Toschi A, Pascale R, Gkrania-Klotsas E, Navarro PO, Canziani LM, Tavelli A, Antinori A, Grossi PA, Peghin M, Tacconelli E, Palacios-Baena ZR, Viale P, Giannella M; Expert team and ORCHESTRA WP4 working group; Expert team Group Authorship; WP4 Working group.
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.
Tavelli, A., Vergori, A., Cingolani, A., Bai, F., Azzini, A. M., Hara, G. L., Caponcello, M. G., Rinaldi, M., Palacios-Baena, Z. R., Gatti, M., Maccarrone, G., Tacconelli, E., Antinori, A., Monforte, HIV Expert Panel.
Objectives
The interaction between HIV and COVID-19 resulted in a syndemic that showed an excess burden of disease for people with HIV (PWH). Four years of the COVID-19 pandemic have raised many unsolved questions about the optimal care of COVID-19 in PWH.
Methods
We performed a study using a three-round Delphi methodology involving a panel of physicians with expertise in HIV and COVID-19 infections. The main aim of the study was to provide recommendations on critical clinical issues of COVID-19 among PWH and to inform physicians and policy-makers for improving care and prevention of COVID-19 in PWH. A total of 27 questions were conceived, focusing on four main areas of interest in the management of COVID-19 in PWH; a panel of 34 experts in HIV and COVID-19 care expressed their level of agreement on each item. Questions that received agreement/disagreement ≥79.4% of panellists were identified and statements were generated accordingly.
Results
Consensus was reached on 19/27 items, resulting in 18 final statements. These statements addressed: (a) risk of COVID-19 progression to severe disease among PWH; (b) COVID-19 diagnostics and laboratory procedures; (c) early treatments with antivirals and/or monoclonal antibodies; (d) use of corticosteroids; (e) COVID-19 preventive strategies.
Discussion
This consensus's study guides infectious diseases physicians in making decisions regarding the care of PWH for COVID-19, where results from the scientific literature are limited or conflicting.
Canziani, L. M., Azzini, A. M., Salmanton-García, J., Savoldi, A., Caponcello, M. G., Pasquini, Z., Pagano, L., Cornely, O. A., Cingolani, A., Mazzotta, V., Cosentino, F., Baño, J. R., Krampera, M., Tacconelli, E., Haematology Expert Team.
Objectives
COVID-19 poses a significant risk to individuals with haematological malignancies (HM), as they are particularly vulnerable to severe disease progression and hospitalization due to their compromised immune systems. Many clinical decisions regarding the management of COVID-19 in these patients are yet to be fully addressed by existing guidelines, leading to variability in care.
Methods
A 28-item Delphi survey was developed to gather expert opinions on key areas of COVID-19 management in patients with HM, including risk stratification for severe COVID-19, diagnostic processes, and treatment decisions.
Results
Twenty-one experts with backgrounds in haematology and infectious diseases were enrolled. Of the 28 questions posed to the experts, consensus was reached on 15 statements.
Discussion
These Delphi consensus statements offer valuable suggestions with direct implications for clinical practice, addressing critical areas such as risk identification, appropriate diagnostic approaches, and tailored treatment strategies for patients with HM with COVID-19. The findings provide actionable insights that may help fill gaps in current scientific literature, enhancing patient care and decision-making in this high-risk population.
Caponcello MG, Navarro PO, Bonazzetti C, Campoli C, Savoldi A, Gentilotti E, Monforte AD, Lo Caputo S, Otero-Varela L, Castrejón I, Tacconelli E, Rodríguez-Baño J, Palacios-Baena ZR; Rheumatological Expert team; Mendoza DM, Navarrete VM, Tomelleri A, Ljung L, Rocha TM, Palma P, Palacios-Baena ZR, Salamanca-Rivera E, Paniagua-García M, Fassio A, Bixio R, Tombetti E, Garufi C, Conti F; ORCHESTRA WP4 working group.
Objectives
The clinical management of COVID-19 in immunocompromised patients remains a challenge. This work aimed to develop a consensus to establish recommendations for the clinical, diagnostic, and therapeutic management of patients with rheumatic diseases and COVID-19.
Methods
A panel of 14 international experts was selected, and Delphi methodology was used for the consensus, after a systematic literature review. Twenty-four questions were formulated and presented to the panel. The experts voted using a 6-point Likert scale (1) ‘Strongly disagree’ (SD); (2) ‘Disagree’ (D); (3) ‘Somewhat disagree’ (SWD); (4) ‘Somewhat agree’ (SWA); (5) ‘Agree’ (A); (6) ‘Strongly agree’ (SA). To establish consensus, simple or cumulative agreement ≥80% was required over a maximum of three rounds. Cumulative agreement was defined as the sum of response percentages on items 1–2 (SD + D); 2–3 (D + SWD); 4–5 (SWA + A); or 5–6 (A + SA), distinguishing a strong degree of agreement (A + SA) or disagreement (SD + D) from a moderate degree of agreement (SWA + A) or disagreement (D + SWD).
Results
After the three rounds, consensus was reached on 23 of the 24 questions and 10 recommendations were made.
Discussion
The Delphi methodology allowed consensus on recommendations in areas with insufficient scientific evidence, which can be considered for decision-making in the management of patients with rheumatological diseases while awaiting better evidence.
Gentilotti E, Canziani L. M, Caponcello M. G, Azzini A. M, Savoldi A, De Nardo P, Palacios-Baena Z. R, Tazza B, Caroccia N, Marchetti G. Antinori A, Giannella M, Rodríguez-Baño J, Tacconelli E, Expert team, Expert team ORCHESTRA SOT panel, Expert team ORCHESTRA PWH panel, Expert team ORCHESTRA RD panel, Expert team ORCHESTRA HM panel, & ORCHESTRA WP4 working group.
Objectives
Post-COVID-19 condition (PCC) remains poorly understood, especially in clinically vulnerable groups. We applied the Delphi approach to drive recommendations for the diagnosis, management, and prevention of PCC in people living with HIV (PWH) and patients affected by rheumatological diseases (RD) and haematological malignancies.
Methods
On the basis of literature review, three areas of interest in PCC in PWH, haematological malignancies, and RD were identified: (a) features and risk factors; (b) diagnosis and management; and (c) prevention. A three-round Delphi anonymous survey consisting of 15 questions was conducted including 69 experts. Consensus was measured by the six-point Likert scale categorized into four tiers: strong disagreement, moderate disagreement, moderate agreement, and strong agreement. Statements were generated on questions achieving consensus.
Results
Eleven statements were generated: six on features and risk factors of PCC in clinically vulnerable populations, two on diagnosis and management, and three on prevention. Chronic fatigue was identified as the most frequent presentation of PCC in PWH and RD populations. A different case definition of PCC is required for RD population, as symptoms of PCC and autoimmune disorders may overlap. Risk factors for PCC include age >65, severity of COVID-19, and female sex; the latter is also associated with increased smell/taste impairment. A clinical assessment or a routine laboratory test performed 3 months after acute infection is not suggested to diagnose PCC in PWH. PWH and RD should be screened to exclude additional autoimmune disorders in case of chronic fatigue/arthralgia of new onset. Full-course vaccination and early treatment for COVID-19 should be promoted to prevent PCC, whereas corticosteroids during acute infection are not recommended.
Discussion
Diagnosis, management, and prevention of PCC are still under discussion. This Delphi offers valuable insights on PCC in selected clinically vulnerable populations and suggests a tailored approach in vulnerable populations.
See the full supplemental issue: https://www.sciencedirect.com/journal/clinical-microbiology-and-infection/vol/31/issue/8/suppl/S
Find out more about the ORCHESTRA project: https://www.id-care.net/projects/orchestra-
The ORCHESTRA project, coordinated by Prof. Tacconelli and the ID-CARE team at the University of Verona, is funded by the European Union’s Horizon 2020 research and innovation programme and started on December 2020 with the aim of tackling the coronavirus pandemic.
The project involves 37 partners from 15 countries, establishing an international large-scale-cohort to generate rigorous evidence in the field of prevention and treatment of SARS-CoV-2 infection. The identification of clinical and laboratory predictors to reduce severity and hospitalisation of COVID-19 and to prevent long COVID are among the main objectives of the project.
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