Lactoferrin for Prevention of COVID-19 in Health Care Workers

NCT04526821 | Terminated Phase 2 DMC

• 1 other identifier: SIDISI 202110
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 2

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.

Conditions

SARS-CoV-2

Keywords

SARS-CoV-2 Infection; Lactoferrin; Health Care Workers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Severity of the COVID-19 infection

  Twelve weeks

• Duration of symptoms of the COVID-19 infection

  Twelve weeks

• Frecuency of symptoms of the COVID-19 infection

  Twelve weeks

Study Arms (2)

Bovine Lactoferrin

EXPERIMENTAL

Bovine Lactoferrin plus standard measures of personal protection.

Drug: Bovine Lactoferrin

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin plus standard measures of personal protection.

Dietary Supplement: Maltodextrin

Interventions

Bovine Lactoferrin 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.

Also known as: Lactoferrin

Bovine Lactoferrin

Maltodextrin 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.

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• Hospital Nacional Arzobispo Loayza: collaborator

Study Sites (2)

Hospital Nacional Arzobispo Loayza

Lima, Lim, 15082, Peru

Location

Hospital Cayetano Heredia

Lima, 15102, Peru

Location

Related Publications (8)

• 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.

  PMID: 27234406 BACKGROUND

• 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.

  PMID: 22292559 BACKGROUND

• 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.

  PMID: 32738305 BACKGROUND

• 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.

  PMID: 21887302 BACKGROUND

• 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.

  PMID: 32664543 BACKGROUND

• 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.

  PMID: 32577649 BACKGROUND

• 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

  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.

  PMID: 36474100 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Lactoferrin; maltodextrin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Theresa J Ochoa, MD, PhD

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 26, 2020
• Study Start: October 17, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: December 9, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication of the study,
• Access Criteria: Contact the study PI ( Theresa.ochoa@upch.pe)

Locations

PE (2)