Nutrients (Mar 2023)
Effect of Lactoferrin on Clinical Outcomes of Hospitalized Patients with COVID-19: The LAC Randomized Clinical Trial
- Erica Matino,
- Elena Tavella,
- Manuela Rizzi,
- Gian Carlo Avanzi,
- Danila Azzolina,
- Antonio Battaglia,
- Paolo Becco,
- Mattia Bellan,
- Giovanni Bertinieri,
- Massimo Bertoletti,
- Giuseppe Francesco Casciaro,
- Luigi Mario Castello,
- Umberto Colageo,
- Donato Colangelo,
- Davide Comolli,
- Martina Costanzo,
- Alessandro Croce,
- Davide D’Onghia,
- Francesco Della Corte,
- Luigi De Mitri,
- Valentina Dodaro,
- Filippo Givone,
- Alessia Gravina,
- Luca Grillenzoni,
- Graziano Gusmaroli,
- Raffaella Landi,
- Anna Lingua,
- Roberto Manzoni,
- Vito Marinoni,
- Bianca Masturzo,
- Rosalba Minisini,
- Marina Morello,
- Anna Nelva,
- Elena Ortone,
- Rita Paolella,
- Giuseppe Patti,
- Anita Pedrinelli,
- Mario Pirisi,
- Lidia Ravizzi,
- Eleonora Rizzi,
- Daniele Sola,
- Mariolina Sola,
- Nadir Tonello,
- Stelvio Tonello,
- Gigliola Topazzo,
- Aldo Tua,
- Piera Valenti,
- Rosanna Vaschetto,
- Veronica Vassia,
- Erika Zecca,
- Nicoletta Zublena,
- Paolo Manzoni,
- Pier Paolo Sainaghi
Affiliations
- Erica Matino
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Elena Tavella
- Department of Maternal-Infant Medicine, Ospedale degli Infermi, 13875 Ponderano, Italy
- Manuela Rizzi
- Department of Health Sciences, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Gian Carlo Avanzi
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Danila Azzolina
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Antonio Battaglia
- Division of Dermatology, Ospedale degli Infermi, 13875 Ponderano, Italy
- Paolo Becco
- Division of Oncology, Ospedale degli Infermi, 13875 Ponderano, Italy
- Mattia Bellan
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Giovanni Bertinieri
- Division of Internal Medicine, Ospedale degli Infermi, 13875 Ponderano, Italy
- Massimo Bertoletti
- Division of Pneumology, Ospedale degli Infermi, 13875 Ponderano, Italy
- Giuseppe Francesco Casciaro
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Luigi Mario Castello
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Umberto Colageo
- Intensive Care Unit, Ospedale degli Infermi, 13875 Ponderano, Italy
- Donato Colangelo
- Department of Health Sciences, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Davide Comolli
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Martina Costanzo
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Alessandro Croce
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Davide D’Onghia
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Francesco Della Corte
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Luigi De Mitri
- Division of Diabetology and Endocrinology, Ospedale degli Infermi, 13875 Ponderano, Italy
- Valentina Dodaro
- Internal Medicine, Department of Medical Sciences, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza, University of Turin School of Medicine, 10126 Turin, Italy
- Filippo Givone
- Division of Pneumology, Ospedale degli Infermi, 13875 Ponderano, Italy
- Alessia Gravina
- Division of Emergency Medicine, Ospedale degli Infermi, 13875 Ponderano, Italy
- Luca Grillenzoni
- Division of Emergency Medicine, Ospedale degli Infermi, 13875 Ponderano, Italy
- Graziano Gusmaroli
- Division of Neurology, Ospedale degli Infermi, 13875 Ponderano, Italy
- Raffaella Landi
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Anna Lingua
- Division of Infectious Disease, Ospedale degli Infermi, 13875 Ponderano, Italy
- Roberto Manzoni
- Division of Dermatology, Ospedale degli Infermi, 13875 Ponderano, Italy
- Vito Marinoni
- Division of Geriatric Care, Ospedale degli Infermi, 13875 Ponderano, Italy
- Bianca Masturzo
- Division of Obstetrics and Gynecology, Ospedale degli Infermi, 13875 Ponderano, Italy
- Rosalba Minisini
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Marina Morello
- Division of Emergency Medicine, Ospedale degli Infermi, 13875 Ponderano, Italy
- Anna Nelva
- Division of Diabetology and Endocrinology, Ospedale degli Infermi, 13875 Ponderano, Italy
- Elena Ortone
- Division of Geriatric Care, Ospedale degli Infermi, 13875 Ponderano, Italy
- Rita Paolella
- Division of Emergency Medicine, Ospedale degli Infermi, 13875 Ponderano, Italy
- Giuseppe Patti
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Anita Pedrinelli
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Mario Pirisi
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Lidia Ravizzi
- Division of Pneumology, Ospedale degli Infermi, 13875 Ponderano, Italy
- Eleonora Rizzi
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Daniele Sola
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Mariolina Sola
- Division of Emergency Medicine, Ospedale degli Infermi, 13875 Ponderano, Italy
- Nadir Tonello
- Division of Emergency Medicine, Ospedale degli Infermi, 13875 Ponderano, Italy
- Stelvio Tonello
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Gigliola Topazzo
- Division of Diabetology and Endocrinology, Ospedale degli Infermi, 13875 Ponderano, Italy
- Aldo Tua
- Division of Emergency Medicine, Ospedale degli Infermi, 13875 Ponderano, Italy
- Piera Valenti
- Department of Public Health and Infectious Diseases, University of Rome, La Sapienza, 00185 Rome, Italy
- Rosanna Vaschetto
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Veronica Vassia
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Erika Zecca
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- Nicoletta Zublena
- Division of Palliative Care, Ospedale degli Infermi, 13875 Ponderano, Italy
- Paolo Manzoni
- Department of Maternal-Infant Medicine, Ospedale degli Infermi, 13875 Ponderano, Italy
- Pier Paolo Sainaghi
- Department of Translational Medicine, Università del Piemonte Orientale (UPO), 28100 Novara, Italy
- DOI
- https://doi.org/10.3390/nu15051285
- Journal volume & issue
-
Vol. 15,
no. 5
p. 1285
Abstract
As lactoferrin is a nutritional supplement with proven antiviral and immunomodulatory abilities, it may be used to improve the clinical course of COVID-19. The clinical efficacy and safety of bovine lactoferrin were evaluated in the LAC randomized double-blind placebo-controlled trial. A total of 218 hospitalized adult patients with moderate-to-severe COVID-19 were randomized to receive 800 mg/die oral bovine lactoferrin (n = 113) or placebo (n = 105), both given in combination with standard COVID-19 therapy. No differences in lactoferrin vs. placebo were observed in the primary outcomes: the proportion of death or intensive care unit admission (risk ratio of 1.06 (95% CI 0.63–1.79)) or proportion of discharge or National Early Warning Score 2 (NEWS2) ≤ 2 within 14 days from enrollment (RR of 0.85 (95% CI 0.70–1.04)). Lactoferrin showed an excellent safety and tolerability profile. Even though bovine lactoferrin is safe and tolerable, our results do not support its use in hospitalized patients with moderate-to-severe COVID-19.
Keywords