Official Title
Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory Therapy in Patients Diagnosed With COVID-19 Disease
Brief Summary

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.

Detailed Description

The World Health Organization (WHO) declared the coronavirus (SARS-CoV-2, COVID-19) outbreak
a Public Health Emergency of International Concern with a pandemic spread. The situation is
rapidly evolving, which raises the approach of reproposing already approved drugs to meet the
emerging challenge and to save time and money. Lactoferrin (Lf) is a natural glycoprotein
that broadly distributed within the body fluids and found predominantly in milk. It
represents a known component of the innate immune system. The antiviral activity of Lf has
been reported against many viruses, including SARS-CoV-1, through blocking the viral
receptors on the host cells preventing them from entry and replication. Markedly, data
reveals that Lf interacts with Heparan Sulfate Proteoglycans (HSPGs) and Angiotensin
Converting Enzyme 2 (ACE2) receptors that are reported as SARS-CoV-2-binding sites to enter
the host cell, suggesting a potential significance of Lf as an antiviral against SARS-CoV-2.
Moreover, the immunoregulatory effects of Lf can protect against the cytokine-storm and
thrombotic complications that result from the COVID-19-induced over-stimulated inflammatory
response and exaggerated immune reactions. In addition, Lf can decrease the free iron
toxicity caused by the virus as it has a strong iron chelating ability. Lf is a safe approved
food supplement that is available in the markets for enhancement of immunity and for
treatment of anemia. The aim of this study is to perform a randomized, double-blind,
placebo-controlled, two arms, clinical trial to assess oral enteric-coated tablet of bovine
apolactoferrin (the low iron-content form of Lf) as a safe antiviral and immunoregulatory
therapy in patients diagnosed with COVID-19 disease.

Not yet recruiting
Corona Virus Infection
Middle East Respiratory Syndrome (MERS)
Acute Respiratory Distress Syndrome
Coronavirus Infection
COVID-19
SARS-CoV 2

Dietary Supplement: Lactoferrin (Apolactoferrin)

Apolactoferrin is an iron-free Lactoferrin (with very low iron saturation). Lactoferrin (Lf) is a natural glycoprotein that is found predominantly in milk. Lf represents a known component of the innate immune system present in neutrophil-specific granules and broadly distributed within the body fluids and exocrine secretions.

Drug: Placebo of excipient(s) will be administered

Placebo of the equivalent excipient will be administered to placebo group
Other Name: excipient(s)

Eligibility Criteria

Inclusion Criteria:

- Patients tested positive (PCR) for SARS-CoV-2 and clinically symptomatic.

- Adult patients with age >18 years.

- Patients willing and able to sign the study informed consent form.

Exclusion Criteria:

- Critically severe disease patients (having Respiratory failure requiring mechanical
ventilation, or signs of septic shock or multiple organ failure requiring ICU
admission).

- Patients who are unconscious

- Patients who have convulsions

- Patients suffering from central cyanosis with SPO2< 90% (for asthmatic patients with
SPO2<88%)

- Pregnant or lactating women

- Patients with a known history of pro-inflammatory diseases (patients with autoimmune
diseases, patients receiving chemotherapy for cancer, patients with malabsorption,
patients with inflammatory bowel disease, Crohn's disease or ulcerative colitis).

- History or suspected immunosuppressive or immunodeficient state including HIV
infection, or chronic immunosuppressant medication (more than 14 days) within the past
3 months (inhaled and topical steroids are allowed).

- Patients with severe renal impairment (GFR <60 ml/min/1.73m2 as measured by the
Cockcroft-Gault formula).

- Patient with severe hepatic impairment, biliary cirrhosis or cholestasis

- Patients who received immunoregulatory therapy within one month before the start of
the study.

- Patients with Known or suspected allergy or any contraindications to Lactoferrin.

- Any condition, according to the judgment of the investigator, would interfere with the
patient's ability to comply with all study requirements or that would place the
patient at unacceptable risk by his/her participation in the study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Egypt
Locations

National Research Center, Egypt (Clinical and Molecular Pharmacology)
Cairo, Giza, Egypt

Clinmax CRO (Clinical Research Organization)
Cairo, Egypt

Clinical Trial Unit National Research Center
Cairo, Egypt

Egyptian Military Medical Services (Hospitals)
Cairo, Egypt

Contacts

Rehab Hegazy, PhD
+201001507676
rehab_hegazy@hotmail.com

Osama Azmy, MD
+201223103084
osamaazmy@yahoo.com

Rehab Hegazy, PhD, Study Director
National Research Center

Egyptian Military Medical Services
NCT Number
Keywords
Lactoferrin
Apolactoferrin
Immuno-modulatory
Cytokine-storm
Antiviral
2019nCoV
2019 new coronavirus (2019nCoV)
Middle East Respiratory Syndrome (MERS)
Acute Respiratory Distress Syndrome (ARDS)
Covid-19
SARS-CoV 2
MeSH Terms
Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Lactoferrin