Effect of Lactoferrin on Clinical Outcomes of Hospitalized Patients with COVID-19: The LAC Randomized Clinical Trial
- E. Matino
- E. Tavella
- M. Rizzi
- G. Avanzi
- D. Azzolina
- Antonio Battaglia
- Paolo Becco
- M. Bellan
- G. Bertinieri
- M. Bertoletti
- G. F. Casciaro
- L. Castello
- Umberto Colageo
- D. Colangelo
- Davide Comolli
- Martina Costanzo
- Alessandro Croce
- Davide D’Onghia
- F. Della Corte
- Luigi De Mitri
- Valentina Dodaro
- Filippo Givone
- A. Gravina
- L. Grillenzoni
- G. Gusmaroli
- R. Landi
- A. Lingua
- R. Manzoni
- V. Marínoni
- Bianca Masturzo
- R. Minisini
- Marina Morello
- A. Nelva
- Elena Ortone
- Rita Paolella
- G. Patti
- A. Pedrinelli
- M. Pirisi
- Lidia Ravizzi
- E. Rizzi
- D. Sola
- Mariolina Sola
- Nadir Tonello
- S. Tonello
- Gigliola Topazzo
- Aldo Tua
- P. Valenti
- R. Vaschetto
- V. Vassia
- E. Zecca
- Nicoletta Zublena
- P. Manzoni
- P. Sainaghi
What this study found
No significant differences were found between the lactoferrin and placebo groups in key outcomes including ICU admissions, mortality rates, and overall clinical recovery. The results suggest that lactoferrin does not provide additional benefits for hospitalized patients with moderate-to-severe COVID-19.
- Study & population
- 218 hospitalized adult patients with moderate-to-severe COVID-19 were randomly assigned to receive either bovine lactoferrin or placebo, alongside standard COVID-19 treatments, from January to May 2021.
- Intervention
- A randomized double-blind placebo-controlled trial was conducted to evaluate the efficacy and safety of 800 mg/day of oral bovine lactoferrin in hospitalized patients with moderate-to-severe COVID-19, in addition to standard COVID-19 therapy.
- Key limitation
- The trial was conducted during a pandemic, and some variability in patient treatment may exist.
View source
Open PDFOriginal 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.