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

doi:10.3390/nu15051285

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 MitriValentina 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

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	1285
Journal	Nutrients
Volume	15
Issue number	5
DOIs	https://doi.org/10.3390/nu15051285
Publication status	Published - Mar 2023

Keywords

COVID-19
double-blind clinical trial
lactoferrin
multicenter
placebo-controlled
randomized

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10.3390/nu15051285

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Matino, E., Tavella, E., Rizzi, M., Avanzi, G. C., Azzolina, D., Battaglia, A., Becco, P., Bellan, M., Bertinieri, G., Bertoletti, M., Casciaro, G. F., Castello, L. M., Colageo, U., Colangelo, D., Comolli, D., Costanzo, M., Croce, A., D’Onghia, D., Della Corte, F., ... Sainaghi, P. P. (2023). Effect of Lactoferrin on Clinical Outcomes of Hospitalized Patients with COVID-19: The LAC Randomized Clinical Trial. Nutrients, 15(5), Article 1285. https://doi.org/10.3390/nu15051285

@article{5a0923bf7ba94c008bc73c2c00915d4f,

title = "Effect of Lactoferrin on Clinical Outcomes of Hospitalized Patients with COVID-19: The LAC Randomized Clinical Trial",

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 = "COVID-19, double-blind clinical trial, lactoferrin, multicenter, placebo-controlled, randomized",

author = "Erica Matino and Elena Tavella and Manuela Rizzi and Avanzi, {Gian Carlo} and Danila Azzolina and Antonio Battaglia and Paolo Becco and Mattia Bellan and Giovanni Bertinieri and Massimo Bertoletti and Casciaro, {Giuseppe Francesco} and Castello, {Luigi Mario} and Umberto Colageo and Donato Colangelo and Davide Comolli and Martina Costanzo and Alessandro Croce and Davide D{\textquoteright}Onghia and {Della Corte}, Francesco and {De Mitri}, Luigi and Valentina Dodaro and Filippo Givone and Alessia Gravina and Luca Grillenzoni and Graziano Gusmaroli and Raffaella Landi and Anna Lingua and Roberto Manzoni and Vito Marinoni and Bianca Masturzo and Rosalba Minisini and Marina Morello and Anna Nelva and Elena Ortone and Rita Paolella and Giuseppe Patti and Anita Pedrinelli and Mario Pirisi and Lidia Ravizzi and Eleonora Rizzi and Daniele Sola and Mariolina Sola and Nadir Tonello and Stelvio Tonello and Gigliola Topazzo and Aldo Tua and Piera Valenti and Rosanna Vaschetto and Veronica Vassia and Erika Zecca and Nicoletta Zublena and Paolo Manzoni and Sainaghi, {Pier Paolo}",

note = "Publisher Copyright: {\textcopyright} 2023 by the authors.",

year = "2023",

month = mar,

doi = "10.3390/nu15051285",

language = "English",

volume = "15",

journal = "Nutrients",

issn = "2072-6643",

publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",

number = "5",

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Matino, E, Tavella, E, Rizzi, M, Avanzi, GC, Azzolina, D, Battaglia, A, Becco, P, Bellan, M, Bertinieri, G, Bertoletti, M, Casciaro, GF, Castello, LM, Colageo, U, Colangelo, D, Comolli, D, Costanzo, M, Croce, A, D’Onghia, D, Della Corte, F, De Mitri, L, Dodaro, V, Givone, F, Gravina, A, Grillenzoni, L, Gusmaroli, G, Landi, R, Lingua, A, Manzoni, R, Marinoni, V, Masturzo, B, Minisini, R, Morello, M, Nelva, A, Ortone, E, Paolella, R, Patti, G, Pedrinelli, A, Pirisi, M, Ravizzi, L, Rizzi, E, Sola, D, Sola, M, Tonello, N, Tonello, S, Topazzo, G, Tua, A, Valenti, P, Vaschetto, R, Vassia, V, Zecca, E, Zublena, N, Manzoni, P & Sainaghi, PP 2023, 'Effect of Lactoferrin on Clinical Outcomes of Hospitalized Patients with COVID-19: The LAC Randomized Clinical Trial', Nutrients, vol. 15, no. 5, 1285. https://doi.org/10.3390/nu15051285

TY - JOUR

T1 - Effect of Lactoferrin on Clinical Outcomes of Hospitalized Patients with COVID-19

T2 - The LAC Randomized Clinical Trial

AU - Matino, Erica

AU - Tavella, Elena

AU - Rizzi, Manuela

AU - Avanzi, Gian Carlo

AU - Azzolina, Danila

AU - Battaglia, Antonio

AU - Becco, Paolo

AU - Bellan, Mattia

AU - Bertinieri, Giovanni

AU - Bertoletti, Massimo

AU - Casciaro, Giuseppe Francesco

AU - Castello, Luigi Mario

AU - Colageo, Umberto

AU - Colangelo, Donato

AU - Comolli, Davide

AU - Costanzo, Martina

AU - Croce, Alessandro

AU - D’Onghia, Davide

AU - Della Corte, Francesco

AU - De Mitri, Luigi

AU - Dodaro, Valentina

AU - Givone, Filippo

AU - Gravina, Alessia

AU - Grillenzoni, Luca

AU - Gusmaroli, Graziano

AU - Landi, Raffaella

AU - Lingua, Anna

AU - Manzoni, Roberto

AU - Marinoni, Vito

AU - Masturzo, Bianca

AU - Minisini, Rosalba

AU - Morello, Marina

AU - Nelva, Anna

AU - Ortone, Elena

AU - Paolella, Rita

AU - Patti, Giuseppe

AU - Pedrinelli, Anita

AU - Pirisi, Mario

AU - Ravizzi, Lidia

AU - Rizzi, Eleonora

AU - Sola, Daniele

AU - Sola, Mariolina

AU - Tonello, Nadir

AU - Tonello, Stelvio

AU - Topazzo, Gigliola

AU - Tua, Aldo

AU - Valenti, Piera

AU - Vaschetto, Rosanna

AU - Vassia, Veronica

AU - Zecca, Erika

AU - Zublena, Nicoletta

AU - Manzoni, Paolo

AU - Sainaghi, Pier Paolo

PY - 2023/3

Y1 - 2023/3

N2 - 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.

AB - 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.

KW - COVID-19

KW - double-blind clinical trial

KW - lactoferrin

KW - multicenter

KW - placebo-controlled

KW - randomized

UR - http://www.scopus.com/inward/record.url?scp=85149638250&partnerID=8YFLogxK

U2 - 10.3390/nu15051285

DO - 10.3390/nu15051285

M3 - Article

SN - 2072-6643

VL - 15

JO - Nutrients

JF - Nutrients

IS - 5

M1 - 1285

ER -

Effect of Lactoferrin on Clinical Outcomes of Hospitalized Patients with COVID-19: The LAC Randomized Clinical Trial

Abstract

Keywords

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