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

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.; 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, P. P.

doi:10.3390/nu15051285

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.

Effect of Lactoferrin on Clinical Outcomes of Hospitalized Patients with COVID-19: The LAC Randomized Clinical Trial / 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.; 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, P. P.. - In: NUTRIENTS. - ISSN 2072-6643. - 15:5(2023), pp. 1285-1-1285-17. [10.3390/nu15051285]