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Lactoferrin for Prevention of COVID-19 in Health Care Workers

NCT ID: NCT04526821

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-17

Study Completion Date

2021-02-10

Brief Summary

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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

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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.

Conditions

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SARS-CoV-2

Keywords

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SARS-CoV-2 Infection Lactoferrin Health Care Workers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Bovine Lactoferrin

Bovine Lactoferrin plus standard measures of personal protection.

Group Type EXPERIMENTAL

Bovine Lactoferrin

Intervention Type DRUG

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.

Maltodextrin

Maltodextrin plus standard measures of personal protection.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin 600mg daily for 12 weeks (3 chewable tablets of 100mg, twice a day), for 12 weeks plus personal portection provided from the hospital.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Lactoferrin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Nacional Arzobispo Loayza

OTHER

Sponsor Role collaborator

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Theresa J Ochoa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Peruana Cayetano Heredia

Locations

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Hospital Nacional Arzobispo Loayza

Lima, Lim, Peru

Site Status

Hospital Cayetano Heredia

Lima, , Peru

Site Status

Countries

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Peru

References

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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.

Reference Type BACKGROUND
PMID: 27234406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22292559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32738305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21887302 (View on PubMed)

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):4903. doi: 10.3390/ijms21144903.

Reference Type BACKGROUND
PMID: 32664543 (View on PubMed)

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 [Preprint]. 2020 Dec 7:2020.05.27.117184. doi: 10.1101/2020.05.27.117184.

Reference Type BACKGROUND
PMID: 32577649 (View on PubMed)

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

Reference Type BACKGROUND

Navarro R, Paredes JL, Tucto L, Medina C, Angles-Yanqui E, Nario JC, Ruiz-Cabrejos J, Quintana JL, Turpo-Espinoza K, Mejia-Cordero F, Aphang-Lam M, Florez J, Carrasco-Escobar G, Ochoa TJ. Bovine lactoferrin for the prevention of COVID-19 infection in health care personnel: a double-blinded randomized clinical trial (LF-COVID). Biometals. 2023 Jun;36(3):463-472. doi: 10.1007/s10534-022-00477-3. Epub 2022 Dec 7.

Reference Type DERIVED
PMID: 36474100 (View on PubMed)

Other Identifiers

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SIDISI 202110

Identifier Type: -

Identifier Source: org_study_id