A group of Italian researchers have discovered that Lactoferrin, a multifunctional protein of the transferrin family and widely representative in secretory fluids—from milk to saliva and tears—is also sold as an over-the-counter (OTC) supplements that based on recent study indicates, according to the authors ,the potential and safe supplementary role of intranasal liposomal bovine lactoferrin (bLf) in the management of mild-to-moderate and symptomatic COVID-19 patients.
Recently, researchers from Italy published the results of an interesting clinical trial in frontiers in Pharmacology. Does Lactoferrin, a multifunctional cationic glycoprotein secreted by exocrine glands and neutrophils, possess an antiviral activity extending to SARS-CoV-2, the virus behind COVID-19?
First, the team sought out to test its hypothesis via in vitro assays providing lactoferrin antiviral activity through direct attachment of both virus and cell surface components as the team communicates in their abstract. With various results based on levels of concentration, the in silico results strongly supported the team’s hypothesis of detection involving both lactoferrin and the Spike S glycoprotein, in effect inhibiting viral entry into the cells. These results were promising enough to plan and organize clinical trials.
The Clinical Trial
The team organized a formal clinical trial to investigate the effect and tolerability of liposomal lactoferrin formulation as a supplementary nutraceutical agent in mild-to-moderate and asymptomatic COVID-19 patients.
In the study, the investigational team recruited 92 mild-to-moderate (67/92) and asymptomatic (25/92) COVID-19 patients and thus divided into three groups based on the administrative treatment plan 32 of the patients (14 hospitalized and 18 home-based) received oral and intranasal liposomal bovine lactoferrin (bLf) while 32 hospitalized patients received standard of care (hydroxychloroquine, azithromycin and lopinavir/darunavir) while 28 were in home-based isolation and took no medication.
Another 32 participants that were not positive were not treated but added as a control group for ancillary analysis. bLf-supplemented COVID-19 patients obtained an earlier significant (p<0.0001) median rRT-PCR SARS-CoV-2 RNA negative conversion than standard of care-treated and non-treated COVID-19 patients (14.25 vs. 27.13 vs. 32.61 days, respectively).
Those patients that accessed the bLf supplements evidenced materially faster clinical symptoms recovery over the standard of care-treated and non-treated group. Those patients that accessed the bLf-supplements experienced a decrease of either serum ferritin or IL-6 levels or host iron overload, all parameters involving inflammatory dynamics associated with progressing COVID-19. Interestingly, Serum D-dimers decreased in those patients accessing bLf supplemented medication. The study team reported no adverse events.
This group of Italy-based investigators concluded that in both preclinical in vitro and in clinical trials (in vivo), the observations were positive for individuals accessing the supplement called bLf. They speculate that bLf may play a safe role as a supplement for COVID-19 patients with mild-to-moderate and asymptomatic COVID-19.
For a list of study authors, follow the link.