Lactoferrin for Prevention of COVID-19 in Health Care Workers

Study Overview
=================
Brief Summary
-----------------
Clinical trial in health care personnel (physicians, nurses or nurse assistants) to determine the effect of orally-administered bovine lactoferrin to prevent SARS-CoV-2 infection. Participants will be randomized to receive daily bovine lactoferrin plus standard measures during 12 weeks or placebo (maltodextrine) for the prevention of SARS-CoV-2. The target enrollment is 336 participants. Each study participant will be monitored twice a week for symptoms of COVID-19 and if symptoms occur, a RT-PCR will be performed. Additionally, we will evaluate asymptomatic infections, by measuring SARS-CoV-2 serology every 4 weeks.

Detailed Description
-----------------
The SARS-CoV-2 infection has affected more than 100 countries around the world being classified as a pandemic by the World Health Organization. Health care providers are at high risk to become infected with the SARS-CoV-2 due to their continuous exposition to infected patients. Multiple strategies are being developed as potential prophylactic regimens, however to date (4th Aug 2020) none has proven to be effective for preventing the SARS-CoV-2 infection. Lactoferrin, an iron-binding protein with multiple physiological functions (anti-microbial, anti-inflammatory, and immunomodulatory), is one of the most important proteins present in mammalian milk. It has shown to inhibit the SARS entry to target cells by inhibiting the union of the SARS-CoV-2 spike protein with its receptor (ACE-II receptors), blocking the heparan sulfate proteoglycan receptor and it decreases the viral load of SARS-CoV-2 infecting culture cells in in vitro models. The study hypothesis is that lactoferrin given as a daily oral food supplement to health care workers will decrease the frequency of SARS-CoV-2 infection. The investigators will conduct a randomized double blinded placebo control clinical trial in physicians, nurses and nurse assistants who work in areas of care for patients with COVID-19 (emergency, hospitalization, and Intensive Care Unit) in hospitals in Lima, Peru, to determine the effect of bovine lactoferrin on the prevention of COVID-19 infection.

Official Title
-----------------
Bovine Lactoferrin for the Prevention of COVID-19 Infection in Physicians and Nurses in Hospitals in Lima, Peru: a Double Blinded Randomized Clinical Trial (LF-COVID)

Conditions
-----------------
SARS-CoV-2

Intervention / Treatment
-----------------
* Drug: Bovine Lactoferrin
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman over 18 and under 60 years old Physicians or nurses or nurse assitant who work in areas of care for patients with COVID-19 (emergency, hospitalization, and Intensive Care Unit) in hospitals in Lima, Peru. Healthy participants, without COVID-19 suggestive symptoms Participant who wants to participate and signs the informed consent. Exclusion Criteria: Participant who had a previous diagnosis of COVID-19. Participant positive in the initial screening for IgM or IgG or a positive RT-PCR for SARS-CoV-2. Participant with the following comorbidities: hypertension, coronary heart disease, diabetes mellitus, obesity, chronic lung disease, cancer, kidney failure, or other hematological disease. Pregnant woman. Participant that are part of another clinical trial or are taking any supplement or preventive treatment for COVID-19. Participant with known allergy to cow's milk protein.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bovine Lactoferrin<br>Bovine Lactoferrin plus standard measures of personal protection. | Drug: Bovine Lactoferrin<br>* Bovine Lactoferrin 600mg daily for 12 weeks (3 chewable tablets of 100mg , twice a day), for 12 weeks plus personal portection provided from the hospital.<br>* Other names: Lactoferrin;|
| Placebo Comparator: Maltodextrin<br>Maltodextrin plus standard measures of personal protection. | Dietary Supplement: Maltodextrin<br>* Maltodextrin 600mg daily for 12 weeks (3 chewable tablets of 100mg, twice a day), for 12 weeks plus personal portection provided from the hospital.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of COVID-19 infections during the 12 weeks of intervention | The primary study outcome will be defined by IgM, IgG and/or RT-PCR positivity for SARS-CoV 2. | Twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of the COVID-19 infection | Severity of SARS-CoV-2 infection (asymptomatic, mild, moderate, severe infection), assessed by the World Health Organization definitions | Twelve weeks | 
| Duration of symptoms of the COVID-19 infection | Duration of symptomatic SARS-CoV-2 infection defined by the number of days with SARS-CoV-2 symptomatology. | Twelve weeks | 
| Frecuency of symptoms of the COVID-19 infection | Frecuency of symptoms of SARS-CoV-2 infection: fever, fatigue, nonproductive cough, anorexia, myalgias, dyspnea, productive cough, taste and smell disorders, headache, rhinorrhea, nausea, diarrhea, and abdominal pain | Twelve weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2 Infection, Lactoferrin, Health Care Workers