Protocol Description
Lactoferrin (Lf) is an iron-binding glycoprotein, present in various mucosal epithelial cells that are also usually found in secretory fluids such as tears, saliva, and nasal secretions (1). Lf transports iron in the blood and is an important component in natural immunity, with multiple biological activities (2), (3), (4). The antiviral activity of the Lf has been widely described (4), (5), (6), (7), (8), (9), (10) (11), (12).
Bovine Lactoferrin (bLf) is considered by the U.S. Food and Drug Administration (FDA) as generally recognized as safe (GRAS) with no contraindications. It is widely used as a nutritional additive in infant formula (8). New formulations such as Liposomal bovine lactoferrin (LbLf) have emerged within the last few years (10), (13), (1), (14). Lf and LbLf act as an ACE2 blocker that prevents the binding of SARS-CoV-2 spike protein (S protein) to the host cell, preventing the virus from being fused to the cell membrane (15), (11), (16), (12). Despite the widespread availability of SARS-CoV-2 vaccines, many individuals are either not vaccinated, not fully vaccinated, or cannot mount adequate responses to the virus (17). Nowadays, with the emergence of the SARS-CoV-2 variants resistant to antibodies (18), (19) or more contagious, and lethal (20), even vaccinated individuals can be infected (21), (22), (23). Reinfection is also a new feature of the emergent variants. Therefore, the search for other COVID-19 treatment options that are not dependent on the antibody's actions is a necessity.
In Sesderma LACTYFERRIN™ Forte (LbLf), Lf derived from bovine milk has been encapsulated in a phosphatidylcholine (PC) nanoliposome particle, which also has a beneficial action related to its size and composition. Because its size (around 100 nm) is smaller than the virus (150 nm), the liposome competes to reach the target cell more quickly and ideally settles before the virus. It may also be able to suppress replication of the virus after it enters the cell (12), as it has been reported for the Human Immunodeficiency Virus (HIV) (5). LbLf also contains vitamin C, which alleviates the effect of viral and bacterial infections, particularly in critically ill patients (24). Even so, until today there is insufficient evidence to recommend either for or against the use of vitamin C for the treatment of COVID-19 patients (25). Lf is believed to be safe along or conjugated with Zinc, as demonstrated in previous clinical trials (13), (5), (10), (26), (27), (28). In Sesderma ZINC Defense™, the Zn that has been encapsulated for faster absorption and higher bioavailability and should contribute to the normal function of the immune system, to the protection of cells from oxidative damage, and to inhibit the replication of the virus (6). There is no con.
Additionally, the liposomes that encase the bLf and Zn in Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ are made of soy lecithin (phosphatidylcholine), which is biodegradable and biocompatible. A dose of 20 ml of Sesderma LACTYFERRIN™ Forte contains 64 mg of bLf and Sesderma ZINC Defense™ contains 20 mg of Zn. LACTYFERRIN™ Forte is pre-registered with the FDA as a food supplement.
Eligibility Criteria
You may be eligible to participate in this study if you meet the following criteria:
Inclusion criteria:
- Patient or legally authorized representative must be willing to sign an informed consent
- Male or female ≥ 18 years of age at the time of enrollment
- COVID-19 diagnosis confirmed by SARS-CoV-2 detection by polymerase chain reaction (PCR) or other commercial or public health assays in any specimen documented by any of the following:
a) PCR positive in samples collected ≤ 72h
b) PCR positive in samples collected > 72h and less than 7 days of disease progression - Mild to moderate symptoms of COVID-19 as determined by investigators following the criteria from NIH COVID-19 Treatment Guidelines for (APPENDIX I. SEVERITY OF ILLNESS CATEGORIES)
Clinical Trial Investigator
Dr. Jose David Suarez, Principal Investigator