LF-COVID: Lactoferrin for Prevention of COVID-19 in Health Care Workers
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Bovine Lactoferrin Bovine Lactoferrin plus standard measures of personal protection. |
Drug: Bovine Lactoferrin
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.
Other Names:
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Placebo Comparator: Maltodextrin Maltodextrin plus standard measures of personal protection. |
Dietary Supplement: Maltodextrin
Maltodextrin 600mg daily for 12 weeks (3 chewable tablets of 100mg, twice a day), for 12 weeks plus personal portection provided from the hospital.
|
Outcome Measures
Primary Outcome Measures
- Number of COVID-19 infections during the 12 weeks of intervention [Twelve weeks]
The primary study outcome will be defined by IgM, IgG and/or RT-PCR positivity for SARS-CoV 2.
Secondary Outcome Measures
- Severity of the COVID-19 infection [Twelve weeks]
Severity of SARS-CoV-2 infection (asymptomatic, mild, moderate, severe infection), assessed by the World Health Organization definitions
- Duration of symptoms of the COVID-19 infection [Twelve weeks]
Duration of symptomatic SARS-CoV-2 infection defined by the number of days with SARS-CoV-2 symptomatology.
- Frecuency of symptoms of the COVID-19 infection [Twelve weeks]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Man or woman over 18 and under 60 years old
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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.
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Healthy participants, without COVID-19 suggestive symptoms
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Participant who wants to participate and signs the informed consent.
Exclusion Criteria:
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Participant who had a previous diagnosis of COVID-19.
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Participant positive in the initial screening for IgM or IgG or a positive RT-PCR for SARS-CoV-2.
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Participant with the following comorbidities: hypertension, coronary heart disease, diabetes mellitus, obesity, chronic lung disease, cancer, kidney failure, or other hematological disease.
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Pregnant woman.
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Participant that are part of another clinical trial or are taking any supplement or preventive treatment for COVID-19.
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Participant with known allergy to cow's milk protein.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital Nacional Arzobispo Loayza | Lima | Lim | Peru | 15082 |
2 | Hospital Cayetano Heredia | Lima | Peru | 15102 |
Sponsors and Collaborators
- Universidad Peruana Cayetano Heredia
- Hospital Nacional Arzobispo Loayza
Investigators
- Principal Investigator: Theresa J Ochoa, MD, PhD, Universidad Peruana Cayetano Heredia
Study Documents (Full-Text)
None provided.More Information
Publications
- Baker HM, Baker EN. A structural perspective on lactoferrin function. Biochem Cell Biol. 2012 Jun;90(3):320-8. doi: 10.1139/o11-071. Epub 2012 Jan 31. Review.
- Campione E, Cosio T, Rosa L, Lanna C, Di Girolamo S, Gaziano R, Valenti P, Bianchi L. Lactoferrin as Protective Natural Barrier of Respiratory and Intestinal Mucosa against Coronavirus Infection and Inflammation. Int J Mol Sci. 2020 Jul 11;21(14). pii: E4903. doi: 10.3390/ijms21144903. Review.
- Chang R, Ng TB, Sun WZ. Lactoferrin as potential preventative and adjunct treatment for COVID-19. Int J Antimicrob Agents. 2020 Sep;56(3):106118. doi: 10.1016/j.ijantimicag.2020.106118. Epub 2020 Jul 30. Review.
- Lang J, Yang N, Deng J, Liu K, Yang P, Zhang G, Jiang C. Inhibition of SARS pseudovirus cell entry by lactoferrin binding to heparan sulfate proteoglycans. PLoS One. 2011;6(8):e23710. doi: 10.1371/journal.pone.0023710. Epub 2011 Aug 22.
- Legrand D. Overview of Lactoferrin as a Natural Immune Modulator. J Pediatr. 2016 Jun;173 Suppl:S10-5. doi: 10.1016/j.jpeds.2016.02.071. Review.
- Marques de Carvalho CA, da Rocha Matos A, Caetano BC, de Sousa Junior IP, da Costa Campos SP, Geraldino BR, et al. In Vitro Inhibition of SARS-CoV-2 Infection by Bovine Lactoferrin [Internet]. Microbiology; 2020 May [cited 2020 May 25]. Available from: http://biorxiv.org/lookup/doi/10.1101/2020.05.13.093781
- Mirabelli C, Wotring JW, Zhang CJ, McCarty SM, Fursmidt R, Frum T, Kadambi NS, Amin AT, O'Meara TR, Pretto CD, Spence JR, Huang J, Alysandratos KD, Kotton DN, Handelman SK, Wobus CE, Weatherwax KJ, Mashour GA, O'Meara MJ, Sexton JZ. Morphological Cell Profiling of SARS-CoV-2 Infection Identifies Drug Repurposing Candidates for COVID-19. bioRxiv. 2020 Dec 7. pii: 2020.05.27.117184. doi: 10.1101/2020.05.27.117184. Update in: Proc Natl Acad Sci U S A. 2021 Sep 7;118(36):.
- SIDISI 202110