Bovine lactoferrin for the prevention of COVID-19 infection in health care personnel: a double-blinded randomized clinical trial (LF-COVID)

Abstract

Lactoferrin (LF) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to determine the effect of bovine lactoferrin (bLF) in the prevention of SARS-CoV-2 infection in health care personnel. A randomized, double-blinded, placebo-controlled clinical trial was conducted in two tertiary hospitals that provide care to patients with SARS-CoV-2 infection in Lima, Peru. Daily supplementation with 600 mg of enteral bLF versus placebo for 90 days was compared. Participants were weekly screened for symptoms suggestive of SARS-CoV-2 infection and molecular testing was performed on suspected episodes. A serological test was obtained from all participants at the end of the intervention. The main outcome included symptomatic and asymptomatic cases. A sub-analysis explored the time to symptomatic infection. Secondary outcomes were the severity, frequency, and duration of symptomatic infection. The study was prematurely cancelled due to the availability of vaccines against SARS-CoV-2 in Peru. 209 participants were enrolled and randomized, 104 received bLF and 105 placebo. SARS-CoV-2 infection occurred in 11 (10.6%) participants assigned to bLF and in 9 (8.6%) participants assigned to placebo without significant differences (Incidence Rate Ratio = 1.23, 95%CI 0.51–3.06, p-value = 0.64). There was no significant effect of bLF on time to symptomatic infection (Hazard Ratio = 1.61, 95%CI 0.62–4.19, p-value = 0.3). There were no significant differences in secondary outcomes. A significant effect of bLF in preventing SARS-CoV-2 infection was not proven. Further studies are needed to assess the effect of bLF supplementation on SARS-CoV-2 infection. Clinical trial registration ClinicalTrials.gov Identifier: NCT04526821, https://clinicaltrials.gov/ct2/show/NCT04526821?term=LACTOFERRIN&cond=COVID-19&cntry=PE&city=Lima&draw=2&rank=1 . Supplementary Information The online version contains supplementary material available at 10.1007/s10534-022-00477-3.

The Multifaceted Roles of Bovine Lactoferrin: Molecular Structure, Isolation Methods, Analytical Characteristics, and Biological Properties

“…According to a recent clinical trial, bLF supplementation (600 mg/day) did not ensure the total protection of the care personnel of a hospital against SARS-CoV-2 infection. 259 SARS-CoV-2 symptoms were confirmed in 11 out of 104 participants (10.6%). Nor was any evident effect observed during a 30 day treatment of SARS-CoV-2 infected patients with a daily dose of 800 mg of bLF.…”

“…On the contrary, in vivo results were not satisfactory enough. According to a recent clinical trial, bLF supplementation (600 mg/day) did not ensure the total protection of the care personnel of a hospital against SARS-CoV-2 infection . SARS-CoV-2 symptoms were confirmed in 11 out of 104 participants (10.6%).…”

Sigma Receptor Ligands Prevent COVID Mortality In Vivo: Implications for Future Therapeutics

“…Lactoferrin has been tested in the clinic for the treatment of COVID becaus antiviral activity, immunomodulatory properties, and safety profile. Such studi garnered highly varied and controversial results, ranging from no observed e symptom resolution in all treated patients [43][44][45][46][47]. This variation can likely be att to methodological differences, including but not limited to the delivery method (i sal spray or oral), type (liposomal or non-liposomal lactoferrin), endpoints, dosag of dosage relative to illness onset, and in one study, use of anti-inflammatory adj With only a 30% reduction in viral replication in vitro, it is not expected that tre Both diphenhydramine and lactoferrin are safe for oral consumption by adult humans.…”

Lactoferrin, a Great Wall of host-defence?

“…Thus, Lf was reported as possessing a potential role in the prevention, treatment, and recovery from COVID-19 infections. Navarro et al ( 2022 ) evaluated the effects of bLf on COVID-19 infections in hospital settings in a clinical trial, but their results showed no significant effects of bLF on COVID-19 infection incidence, severity and symptoms in hospital personnel. However, liposomal bLf was used through oral and intranasal administration in COVID-19 in patients with mild-to-moderate disease and in COVID-19 asymptomatic patients; this work suggested a potential role for bLf as significant decreases in serum ferritin, IL-6, and D-dimers levels were seen (Campione et al 2021 ).…”